The Recall Desk

Archive

December 2014 recalls

1,028 recalls were announced in December 2014.

What the numbers show

Critical
72
Severe
272
High
309
Moderate
311
Low
64

Of the 1,028 recalls this month scored against our rubric, 7% are Critical, 26% are Severe.

701–800 of 1028

  • SevereFDA (Devices)·Z-0409-2015·2014-12-10

    Customed C-Section Surgical Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 600 C-Section Surgical Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0403-2015·2014-12-10

    Customed Laparotomy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 288 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Pack, Catalog # 900-848 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0380-2015·2014-12-10

    Customed Laparoscopy Chole Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 440 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Chole Pack, Catalog number 900-414. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0397-2015·2014-12-10

    Customed Cesarean Packs Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 490 Cesarean Packs (Catalog # 900-660) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Cesarean Pack, Catalog # 900-660 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0328-2015·2014-12-10

    Customed Recalls Knee Arthroscopy Packs Due to Sterility Compromise

    Customed, Inc. is recalling 144 Knee Arthroscopy Packs because significant sterility compromises and manufacturing deficiencies may result in patient infection.

    Product
    Knee Arthroscopy Pack, catalog #900-2123 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Food)·F-0597-2015·2014-12-10

    Oasis Brands Recalls Lacteos Santa Martha Cheese Due to Listeria

    Oasis Brands is voluntarily recalling Lacteos Santa Martha brand cheese products after Listeria monocytogenes was detected in samples.

    Product
    Queso Seco Hondureno (Honduran Style Dry Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Seco Hondureno Dry Cheese Net Wt 12oz (340g)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0239-2015·2014-12-10

    Customed Universal Drainage Tray Recalled Due to Compromised Sterility

    Customed, Inc. is recalling Universal Drainage Trays because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Universal Drainage Tray, Catalog number 900-032. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0402-2015·2014-12-10

    Customed Femoral Angiography Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 236 units of Femoral Angiography Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Femoral Angiography Pack, Catalog number 900-796. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0318-2015·2014-12-10

    Customed Recalls Hip Orthopedia Packs Due to Compromised Sterility

    Customed, Inc. is recalling 36 Hip Orthopedia Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Hip Orthopedia Pack, Catalog number 900-1835. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0391-2015·2014-12-10

    Customed Angiography Pack Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 210 Angiography Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Angiography Pack, Catalog number 900-610. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0376-2015·2014-12-10

    Customed Basic Pack W/Out Gown Recalled for Sterility Compromise

    Customed, Inc. is recalling 242 units of Basic Pack W/Out Gown due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Basic Pack W/Out Gown, Catalog number 900-345. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0293-2015·2014-12-10

    Customed D&C Laparoscopy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 108 D&C Laparoscopy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    D&C Laparoscopy Pack, Catalog number 900-1476. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0339-2015·2014-12-10

    Customed Extremity Arm Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 92 Extremity Arm Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Food)·F-0602-2015·2014-12-10

    Oasis Brands Recalls Lacteos Santa Martha Queso Fresco Due to Listeria

    Oasis Brands is voluntarily recalling Lacteos Santa Martha Queso Fresco because Listeria monocytogenes was found in environmental and product samples.

    Product
    Queso Fresco (Fresh Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Queso Fresco Fresh Cheese Net Wt 12oz (340g)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0270-2015·2014-12-10

    Customed OB Packs Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 224 OB Packs used for patient care procedures due to compromised sterility and inadequate storage conditions that may result in patient infection.

    Product
    OB Pack, Catalog number 900-1030. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0358-2015·2014-12-10

    Customed Tummy Tuck and Liposuction Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling six Tummy Tuck & Liposuction Packs due to compromised sterility and manufacturing deficiencies that pose a risk of patient infection.

    Product
    Tummy Tuck & Liposuction Pack, catalog #900-2661 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0295-2015·2014-12-10

    Customed Angiography Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 70 Angiography Packs (Catalog 900-1488) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Angiography Pack, Catalog number 900-1488. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Food)·F-0606-2015·2014-12-10

    Oasis Brands Recalls Lacteos Santa Martha Cream Due to Listeria

    Oasis Brands is voluntarily recalling Lacteos Santa Martha Crema Nica after Listeria monocytogenes was detected in related products and environmental samples.

    Product
    Crema Nica (Nica Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema Nica Grade A Cultured Cream Net WT 1 LB (16 oz)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0363-2015·2014-12-10

    Customed Laparotomy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 288 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Pack, catalog #900-2829 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0302-2015·2014-12-10

    Customed Retina Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 84 Retina Packs because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Retina Pack, Catalog number 900-1611. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0251-2015·2014-12-10

    Customed Wound Management Trays Recalled for Compromised Sterility

    Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Wound Management Tray, Catalog number 900-1154. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0353-2015·2014-12-10

    Customed Medical Device Recall for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 129 medical devices due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Hip & Knee Replacement, catalog #900-2614 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0249-2015·2014-12-10

    Customed Incision and Drainage Trays Recalled for Compromised Sterility

    Customed, Inc. is recalling 9,200 Incision & Drainage Trays because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0319-2015·2014-12-10

    Customed Ophthalmic Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 96 Ophthalmic Packs (Catalog 900-1933) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Ophtalmic Pack, Catalog number 900-1933. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0304-2015·2014-12-10

    Customed Labor and Delivery Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 352 Labor & Delivery Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Labor & Delivery Pack, Catalog number 900-168. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0407-2015·2014-12-10

    Customed Medical Kits Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 100 units of medical kits (Catalog # 900-913) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    , Catalog # 900-913 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0377-2015·2014-12-10

    Customed Cesarean Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 654 Cesarean Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Cesarean Pack, Catalog number 900-403. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0394-2015·2014-12-10

    Customed Fanfold Drape Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 6,300 Fanfold Drapes due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Fanfold Drape, Catalog number 900-633. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0374-2015·2014-12-10

    Customed Impervious Gowns Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 240 impervious gowns due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Gown Impervious Extra Long X-Large with Towel & Wrap, Catalog number 900-3190. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0316-2015·2014-12-10

    Customed Laparoscopy Premium Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 28 units of Laparoscopy Premium Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Premium Pack, Catalog number 900-1803. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0399-2015·2014-12-10

    Customed Recalls Carpal Tunnel Surgical Packs Due to Sterility Compromise

    Customed, Inc. is recalling 660 Carpal Tunnel Surgical Large Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Carpal Tunnel Surgical Large Pack, Catalog # 900-742A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0286-2015·2014-12-10

    Customed Neuro Spine Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 207 Neuro Spine Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Neuro Spine Pack, Catalog number 900-1300 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0271-2015·2014-12-10

    Customed Arthroscopy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 180 Arthroscopy Packs (Catalog 900-1042) because manufacturing and storage deficiencies compromised sterility, posing a risk of patient infection.

    Product
    Arthroscopy Pack, Catalog number 900-1042. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0372-2015·2014-12-10

    Customed Face Lift Recall Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 20 units of Face Lift products (Catalog 900-3083) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Face Lift, Catalog number 900-3083. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0333-2015·2014-12-10

    Customed Ear Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 105 Ear Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Ear Pack, catalog #900-2234 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0364-2015·2014-12-10

    Customed Orthopedic Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 300 Orthopedic Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Orthopedic Pack, catalog #900-2830 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0283-2015·2014-12-10

    Customed Premium Cesarean Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 150 Premium Cesarean Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Premium Cesarean Pack, Catalog number 900-1294 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0327-2015·2014-12-10

    Customed Angiography Pack Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 1,068 Angiography Packs due to significant compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Angiography Pack, catalog #900-210 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0341-2015·2014-12-10

    Customed Arthroscopy Pack Recalled Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 200 Arthroscopy Packs (catalog #900-2473) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Arthroscopy Pack, catalog #900-2473 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0401-2015·2014-12-10

    Customed General Minor Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 680 General Minor Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    General Minor Pack, Catalog # 900-787 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0386-2015·2014-12-10

    Customed Laparoscopy Packs Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 126 Laparoscopy Packs (Catalog 900-486) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0248-2015·2014-12-10

    Customed Utility Drape End Product Recalled for Compromised Sterility

    Customed, Inc. is recalling Utility Drape End Products due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Utility Drape End Product, Catalog number 900-582. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0400-2015·2014-12-10

    Customed Neuro Pack Recalled Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 36 Neuro Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Neuro Pack, Catalog # 900-752 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0289-2015·2014-12-10

    Customed Plastic Surgery Packs Recalled for Compromised Sterility

    Customed, Inc. is recalling 40 Plastic Surgery Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Plastic Surgery Pack, Catalog number 900-1402. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0320-2015·2014-12-10

    Customed Universal Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 45 Universal Packs (Catalog 900-1936) because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Universal Pack, Catalog number 900-1936. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0259-2015·2014-12-10

    Customed Gown Surg Fully Impervious Large Recalled for Compromised Sterility

    Customed, Inc. is recalling 170 units of Gown Surg Fully Impervious Large due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Gown Surg Fully Impervious Large, Catalog number 900-2564. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0405-2015·2014-12-10

    Customed Urology Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 195 Urology Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Urology Pack, Catalog # 900-868 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0307-2015·2014-12-10

    Customed Open Heart Tray Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 160 Open Heart Trays (Catalog 900-170) due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Open Heart Tray, Catalog number 900-170. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0359-2015·2014-12-10

    Customed Debridement Tray Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 50 Debridement Trays (Catalog #900-2702) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0288-2015·2014-12-10

    Customed Open Heart Tray Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 108 Open Heart Trays because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Open Heart Tray, Catalog number 900-1393. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0361-2015·2014-12-10

    Customed Shoulder Packs Recalled Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 126 shoulder packs used for wound care due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Shoulder Pack, catalog #900-2766 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0308-2015·2014-12-10

    Customed Peri Gyn Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 180 units of Peri Gyn Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Peri Gyn Pack, Catalog number 900-1716. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0413-2015·2014-12-10

    Customed Laparotomy Packs Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 372 Laparotomy Packs (Catalog # 900-996) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparotomy Pack, Catalog # 900-996 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0243-2015·2014-12-10

    Customed Suction Catheter Kits Recalled for Compromised Sterility

    Customed, Inc. is recalling Suction Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Suction Catheter Kit, Catalog number 900-277. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0379-2015·2014-12-10

    Customed Cesarean Pack Recalled Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 260 Cesarean Packs (Catalog 900-410) due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Cesarean Pack, Catalog number 900-410. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0393-2015·2014-12-10

    Customed Recalls O.R. Towels Due to Sterility Compromise

    Customed, Inc. is recalling 550 O.R. Towels (Catalog 900-629) because significant sterility compromises and manufacturing deficiencies may result in patient infection.

    Product
    O.R. Towels, Catalog number 900-629. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0382-2015·2014-12-10

    Customed Cysto Tur Pack Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 75 units of Cysto Tur Pack (Catalog 900-430) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0378-2015·2014-12-10

    Customed Major Lap Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 1,680 Major Lap Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Major Lap Pack, Catalog number 900-404. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0404-2015·2014-12-10

    Customed Cesarean Pack Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 264 Cesarean Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Cesarean Pack, Catalog # 900-851 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0398-2015·2014-12-10

    Customed Arthroscopy Surgical Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 400 Arthroscopy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0385-2015·2014-12-10

    Customed Laparoscopy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 48 Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-484 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Food)·F-0603-2015·2014-12-10

    Oasis Brands Recalls Lacteos Santa Martha Fresh Curd Cheese for Listeria

    Oasis Brands is voluntarily recalling Lacteos Santa Martha Fresh Curd Cheese after Listeria monocytogenes was detected in product and environmental samples.

    Product
    Cuajada en Hoja (Fresh Curd Cheese) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd Net Wt 12oz (340g)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0348-2015·2014-12-10

    Customed Minor Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 944 Minor Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Minor Pack, catalog #900-2511 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0265-2015·2014-12-10

    Customed Angiodrape Packs Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 1,152 Angiodrape Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Angiodrape Pack, Catalog number 900-002. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0299-2015·2014-12-10

    Customed Urology Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 284 Urology Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Urology Pack, Catalog number 900-1521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0351-2015·2014-12-10

    Customed Gown Cool Impervious XLGE Breathable Recalled for Sterility Compromise

    Customed, Inc. is recalling 144 units of Gown Cool Impervious XLGE Breathable gowns due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Gown Cool Impervious XLGE Breathable, catalog #900-2592 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0387-2015·2014-12-10

    Customed Laparotomy Basic Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 70 Laparotomy Basic Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Laparotomy Basic Pack, Catalog number 900-547 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0242-2015·2014-12-10

    Customed Tracheotomy Care Kits Recalled for Sterility Compromise

    Customed, Inc. is recalling Tracheotomy Care Kits due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0343-2015·2014-12-10

    Customed Laparoscopy and Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 240 units of Laparoscopy and Pack (catalog #900-2483) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy and Pack (1)(2), catalog #900-2483 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0414-2015·2014-12-10

    Customed Peri Gyn Pack Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 230 units of Peri Gyn Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Peri Gyn Pack, Catalog # 900-997 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0285-2015·2014-12-10

    Customed Premium OB Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 335 Premium OB Packs because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0272-2015·2014-12-10

    Customed Laparoscopy Chole Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 480 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Chole Pack, Catalog number 900-1059. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0406-2015·2014-12-10

    Customed Arthroscopy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 60 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Arthroscopy Pack, Catalog # 900-902 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0370-2015·2014-12-10

    Customed Liposuction Pack Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 20 Liposuction Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Liposuction Pack, Catalog #900-3028 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0266-2015·2014-12-10

    Customed O.B. Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 176 O.B. Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0347-2015·2014-12-10

    Customed Urology Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 222 Urology Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Urology Pack, catalog #900-2510 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0290-2015·2014-12-10

    Customed Umbilical Vessel Catheter Kits Recalled for Compromised Sterility

    Customed, Inc. is recalling 48 Umbilical Vessel Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0306-2015·2014-12-10

    Customed Cesarean Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 126 Cesarean Packs because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Cesarean Pack, Catalog number 900-1689. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0305-2015·2014-12-10

    Customed Laparoscopy Chole Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 246 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Chole Pack, Catalog number 900-1688. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0362-2015·2014-12-10

    Customed Laparotomy Surgical Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 852 Laparotomy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0346-2015·2014-12-10

    Customed Laparotomy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 400 Laparotomy Pack III units due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0375-2015·2014-12-10

    Customed Breat Pack-TPSC Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 63 Breat Pack-TPSC units due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Breat Pack-TPSC, Catalog number 900-3431. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereNHTSA·14V786000·2014-12-10

    Ameritrans Recalls Transit Buses Due to Suspension Tank Mount Failure Risk

    Ameritrans is recalling 2013-2014 F330 and 2013 R330 transit buses because a suspension fluid tank mount may fail, causing the tank to separate and create a road hazard.

    Product
    AMERITRANS — AMERITRANS F330, R330
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0244-2015·2014-12-10

    Customed Urethral Catheter Trays Recalled for Compromised Sterility

    Customed, Inc. is recalling Urethral Catheter Trays due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0331-2015·2014-12-10

    Customed Recalls Shoulder Arthroscopy Packs Due to Sterility Compromise

    Customed, Inc. is recalling 270 units of Shoulder Arthroscopy Packs because compromised sterility and manufacturing deficiencies may lead to patient infection.

    Product
    Shoulder Arthroscopy Pack, catalog #900-2193 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0336-2015·2014-12-10

    Customed Full Body Drape Recalled for Sterility Compromise

    Customed, Inc. is recalling 308 units of General Line Full Body Drapes due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    General Line Full Body Drape, catalog #900-2262 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0268-2015·2014-12-10

    Customed Major Laparotomy Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 840 Major Laparotomy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0282-2015·2014-12-10

    Customed Laminectomy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 180 Laminectomy Packs because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Laminectomy Pack, Catalog number 900-1202. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0415-2015·2014-12-10

    Customed C-Section Pack Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 122 C-Section Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    C-Section Pack, Catalog # 900-998 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0345-2015·2014-12-10

    Customed Transverse Laparotomy Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 204 Transverse Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Transverse Laparotomy Pack (8), catalog #900-2491 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0274-2015·2014-12-10

    Customed Arthroscopy Packs Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 256 Arthroscopy Packs (Catalog 900-1062) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Arthroscopy Pack, Catalog number 900-1062. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0325-2015·2014-12-10

    Customed Laparoscopy Chole Pack Recalled for Compromised Sterility

    Customed, Inc. is recalling 36 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Chole Pack, Catalog number 900-2004. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0593-2015·2014-12-10

    Gourmet Warehouse Red Wine Marinade Recalled for Undeclared Allergens

    R and S Gourmet Warehouse is recalling Red Wine Marinade bottles because the product contains undeclared soy, wheat, and anchovies.

    Product
    Gourmet Warehouse, Red Wine Marinade, 16 fl.oz. (473 mL), Ingredient: Soy Sauce, Salt, Black Pepper, Cayenne Pepper, Garlic, Red Wine, Vinegar, Worcestershire Sauce, Onions and Spices, P.O. Box 22764, Hilton Head Island, SC 29925.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0494-2015·2014-12-10

    Aircraft Medical Recalls McGrath MAC2 Video Laryngoscope Blades

    Aircraft Medical Limited is recalling McGrath MAC2 Video Laryngoscope Blades because the retaining clip may be difficult to engage, increasing the risk of the blade disconnecting during intubation.

    Product
    McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0263-2015·2014-12-10

    Customed Surgical Gowns Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 2,240 surgical gowns due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0255-2015·2014-12-10

    Customed Medical Leggings Recalled Due to Compromised Sterility

    Customed, Inc. is recalling medical leggings used for patient care procedures because compromised sterility and manufacturing deficiencies may increase the risk of patient infection.

    Product
    Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighCPSC·15712·2014-12-10

    Ethan Allen Recalls Harwood Floor Lamps Due to Electrical Shock Risk

    Ethan Allen is recalling Harwood floor lamps because a defect in the line cord insulation poses a risk of electrical shock. One incident of electrical shock has been reported.

    Product
    Harwood Floor Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2015·2014-12-10

    Customed Laparoscopy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 57 Laparoscopy Packs (Catalog 900-1967) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-1967. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0350-2015·2014-12-10

    Customed OB Packs Recalled Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 80 OB Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    OB Pack, catalog #900-254 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0253-2015·2014-12-10

    Customed Surgical Gowns Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 4,710 surgical gowns because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states

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