The Recall Desk

FDA (Devices) recall action 68536

Customed, Inc recalled 233 products on 2014-09-10

The FDA (Devices) publishes a recall like this one as 233 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 233 pages.

Products
233
Announced
2014-09-10
Critical
26
Units
—

Why these products were recalled

Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

76–100 of 233

  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 1,900 units of EO sterilized urology packs across 36 lots because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    UROLOGY PACK- (2) SYRINGE 30ML SLIP TIP 1 ML LIF (2) GOWN SURG. REINFORCED LARGE TOWEL & WRAP (1 0) GAUZE SPONGE 4" X 4" 12 PLY (1) URINARY DRAINAGE BAG 2000ML ANTI-REFLUX LIF (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LITHO 110" X 63" SMS WITH LEGGINS (3) TOWELS…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Cystoscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Cystoscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CYSTOSCOPY PACK Ill (1) (2) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (2) LEGGINGS W/7" CUFF 30" X 42" (1) DRAPE CYSTOSCOPY T 60" X 87" 35" SMS STD (1) GOWN SURG.REINFORCED XL EXTRA LONG LEVEL IV Product Usage: EO…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparoscopy OB GYN Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 345 units of Laparoscopy OB GYN Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEET T LAPAROSCOPY SMS LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DRAPE SHEET 41" X 58" SMS LIF (4) ABSORBENT TOWELS 15" x 20" LIF (1) PVP TRIPLE SWABSTICK IODOPHOR (1) DRAPE LASER CAMERA W/EL 6" X 96"…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls EO Sterilized Surgical Drape Sheets Due to Packaging Integrity

    Customed, Inc. is recalling EO sterilized surgical drape sheets because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 X 24 L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls EO Sterilized Surgical Shoulder Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 327 units of EO sterilized surgical shoulder packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO STAND COVER REINFORCED L/F (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (1) SHEET DRAPE 70"…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Cataract Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling cataract surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Liposuction Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling liposuction packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LIPOSUCTION PACK AESTHETIC SURG.CENTER CONTENTS: (1) BLADE SURG. #11 CARBON STEEL (3) * GLOVE PERRY SURG. # 7LATEX (15) SPONGE LAP PREWASH 18" X 18" XRD L/F (4) * GLOVE PERRY SURG. # 7 LATEX (1) TABLE COVER REINF 50" X 90" LIF (2) GOWN SOFT SMS STD XL SET IN SLEEVE L/F (4)…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls D & C Laparoscopy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling D & C Laparoscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) DRAPE UTILITY UF (1) TRAY MAYO SMALL LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SUTURE BAG FLORAL LIF (1) TUBE SUCTION CONNECT X" X 12' LIF (1)…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Chole Cystectomy All Endo System Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Chole Cystectomy All Endo System kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF (2) MAYO STAND COVER REINFORCED UF (1) NEEDLE HYPODERMIC (6) ABSORBENT TOWEL 15 X 20 UF (1) NEEDLE HYPODERMIC 22G X 1Y. UF (4) UTILITY DRAPE WIT…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Cysto Tur Pack Recalled for Potential Packaging Integrity Issues

    Customed is recalling Cysto Tur Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls General Minor Packs Due to Potential Sterility Loss

    Customed, Inc. is recalling General Minor Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF (2) BOWL UTILITY 16oz LIF (1) TIP CAUTERY POLISHER LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL UTILITY 32oz (1) BAG SUTURE FLORAL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (10) GAUZE SPONGES 4" X 4" 16PLY XRD…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparoscopy Cholecystectomy Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 40 units of laparoscopy cholecystectomy surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP (1) BLADE SURGICAL #11 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) GOWN XLARGE SMS IMPERV.…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 360 units of laparotomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROT 102" X 78" X 121" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN XL SMS IMPERVIOUS…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 1,168 units of laparoscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE (3) DRAPE SHEET 41" X 58" SMS (1) TUBING INSUFFLAT SET…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,700 urology packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12' (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK (1) BASIN RING (1) TUR Y SET, 2 LEAD, ST. (1) BAG SUTURE FLORAL (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV (2) TOWEL CLAMP (1) DRAPE LITHOTOMY…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Face Pack Aesthetic Surgery Kits Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 96 units of Face Pack Aesthetic Surgery kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    FACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR COTION 6" WOOD (60) GAUZE SPONGE 4" X 4" 16 PLY SOFT LIF (2) NEEDLE SPINAL ANEST 22G X 3 Y2 LIF (8) TOWELS CLOTH HUCK BLUE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (6) BLADE #15…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparoscopy Gyn Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 648 units of Laparoscopy Gyn Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) LAPAROSCOPY SHEET "T" SMS (3) TOWELS ABSORBENT 15" X 20" (1) SURGICAL BLADE#11 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) LEGGINS WITH 7" CUFF 30" x 42"…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Surgical Ear Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 123 units of surgical ear packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN lO in 700cc ( I ) GOWN XL SMS IM P. REINFORCED ( I ) NEEDLE HYPODERM IC 1 8G X I 'h ( I ) WASH BASIN ROUND 6QT ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT (I) STERI STR I P…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Ophthalmic Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling ophthalmic surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6" WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Pery Gyn Pack Surgical Kits Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Pery Gyn Pack surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) DRAPE UTILITY (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERV. REINF. AAMI LEVEL Ill (1) DRAPE UNDERBUTIOCK W/POUCH 44" X 35" (1) TIME OUT BEACON NON WOVEN (1) BOWL UTILITY BLUE 16oz (1) BAG SUTURE…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Cysto TUR Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 29 lots of Cysto TUR Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15" X 20" LIF (1) CYSTOSCOPY 'T' DRAPE 60" X 87" X 35" SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Pery Gyn Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Pery Gyn Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED (1) DRAPE UNDERBUTTOCK WITH POUCH (1) UTILITY BOWL 16oz. (10) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) ROBNEL CATHETER 18FR. (1) DRAPE…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Face Pack MRT Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Face Pack MRT surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) DRAPE INST. MAGNETIC 10 X 16 LIF (1) TRAY HALF DEEP (1) COVER MAYO STAND REINFORCED LIF (1) SHEET ENT SPLIT 110 X 77 SMS LIF (1) COVER…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Reyito Urology Packs Due to Potential Sterility Loss

    Customed, Inc. is recalling 2,900 units of Reyito Urology Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABSORBENT UF ( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF ( I) SYRINGE 30cc W/0 NDL. LUER LOCK UF ( I) BAG SUTURE (I) TABLE COVER ( I} TUBE SUCTION CONNECT. W' X 12' UF (10) GAUZE SPONGES 4" X 4"…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 432 units of Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BANDAGE (1 ) ELASTIC BANDAGE 6" X 5yds LIF (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG (1) TUBE SUCTION CONNECTING W X 12' LIF (1) SHEET EXTREMITY ABS. 125" X 85" SMS (1) DRAPE LASER CAMERA W/EL (3)…
    Category
    Distribution
    2 states