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

26–50 of 233

  • HighFDA (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 FLORA
    Category
    Distribution
    2 states
  • CriticalFDA (Devices)··2014-09-10

    Customed Fanfold Drapes Recalled for Potential Packaging Integrity Compromise

    Customed, Inc. is recalling Fanfold Drapes due to potential packaging integrity issues that could compromise sterility and risk patient injury.

    Product
    FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 512 units of arthroscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC 6" X 5yrd. LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) DURAPREP SURGICAL SOLUTION 26m I LIF (1) STOCKINETIE IMPERVIOUS (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS
    Category
    Distribution
    2 states
  • CriticalFDA (Devices)··2014-09-10

    Customed Recalls Endoveneous Custom Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 12 lots of Endoveneous Custom Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (3) GOWN SMS X-LARGE STD NON REINFORCED ( 1) TABLE COVER 44" X 90" (4) DRAP
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,233 units of EO sterilized surgical laparotomy packs because packaging integrity may be compromised, risking product contamination or loss of sterility.

    Product
    LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" (2) GOWN XLARGE SMS IMPERVIOUS REINFORCED (1) COVER MAYO STAND REINFORCED (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROTOMY 102" X 78" X 1
    Category
    Distribution
    2 states
  • HighFDA (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) DRAPE UTILITY WITH TAPE UF (1) UNDERBUTTOCK DRAPE WITH POUCH (2) ABSORBENT TOWELS 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1) TABLE COVER REINFORCED 50" X 90" UF (1) ABDOMINAL DRAPE WITH TAPE UF (1) UTILITY BOWL 16oz. (1 0) GAUZE SPONGE 4" X
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 47 lots of EO-sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. (1 0) LAP SPONGES PRE-WASH 18" x 18" XRD (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41" x 58" SMS LIF (2) TUBE SUCTION CONNECT. Y.." X 12' LIF (1
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 14 lots of Urology Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    UROLOGY PACK - (3) TOWELS ABSORBENT 15" X 20" UF (1) WASH BASIN ROUND 6QT. (1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN (1) BAG URINARY DRAINGAGE 2000ml ANTI-REFLUX (1) BAG SUTURE FLORAL (1) GOWN SURG. REINFORCED X-LARGE T/VIJRAP (1) TABLE COVER 44" X 90" UF (2) DRAP
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Universal Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Universal Packs containing surgical items due to potential packaging integrity issues that could compromise sterility.

    Product
    Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) BAG SUTURE FLORAL (1) DRAPE TOP WITH ADHESIVE 100" X 53"
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

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

    Product
    LAPAROTOMY PACK 1 (2&3) CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITHffAPE (1) SUTURE BAG FLORAL (1) DRAPE T LAPAROT 102" X 78" X 121" STD SMS (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Extremity Pack Recall Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Extremity Packs (code 900-2615) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) ELASTIC BANDAGE WITH VELCRO 4 X 5 (2) BLADE SURGICAL# 15 STAINLES STEEL (4) DRAPE UTILITY WITH TAPE (1) GOWN XL SMS IMPERVIOUS REINFORCED ( 1) GOWN SURG REINFORCED LARGE TOWEL & WRAP (1) SKIN
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Premium O.B. Packs Due to Packaging Integrity Concerns

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

    Product
    PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50" X 90" LIF (10) GAUZE SPONGES 4" X 4" 12PLY LIF (2) LEGGINS WITH 7" CUFF 30" x 42" LIF (2) PAD OBSTETRICAL X-LARGE ST. (2) SHEET DRAPE 42" X 55" LIF (1) UNDERBUTTOCK DRAPE WITH POUCH LIF (1) DRAPE ABDOMINAL 40" X
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Ortho Implant Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z" (1) TUBE SUCTION CONNECT. }4" X 12' (1) DURAPREP SURGICAL SOLUTION 26ml (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Knee Arthroscopy Packs Due to Packaging Integrity Concerns

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

    Product
    Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDING CAST SOFT ROLL 6 X 4yds. (1) GOBAN SELF-ADHERENT WRAP 6 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (10) GAUZE SPONGES 4 X 4 16PLY XRD (3) NEEDLE HYPODERM
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Foley Catheter Kits Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 13 lots of Foley Catheter Kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM (1) TOWEL 3PL Y POLY 17" X 18" (2) SWABSTICK DRY COTTON (1)
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 20 lots of arthroscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) BLADE SURGICAL # 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1 ~ LIF (1) TUR Y SET 81
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Pery Gyn Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF (1) TOWEL ABSORBENT 15" X 20" UF (2) LEGGINGS W/7" CUFF 30" X 42" (1) TABLE COVER REINFORCED 44" X 78" UF (1) DRAPE UNDERBUTTOCK WITH POUCH EO sterilized surgical convenient packs packaged into polyester/polyeth
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 552 units of EO sterilized surgical packs because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.

    Product
    LAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15" x 20" LIF (2) LEGGINS WITH 7" CUFF (1) LAPAROSCOPY T SHEET SMS (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) *ROBIN REDRUBBER CATHETER 14FR LATEX (1) DRAPE LASER CAMERA W/EL LIF (1) PAD OBST
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Cardiovascular Case Carts Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 48 units of Cirugia Cardiovascular Case Carts because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIOVASCULAR .(INDUCCION) (1) CIRUGIA CARDIOVASCULAR (CIRUGIA ) (1) CIRUGIA CARDIOVASCULAR (PREP ENFERMERA CIRCULANTE) (1) CIRUGIA CARDIOVASCULAR (PERFUSION SUPPLIES) (1) CIRUGIA CARDIOVASCULAR (POST
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 93 units of Laparotomy Packs (900-2516) because packaging integrity may be compromised, risking product contamination or loss of sterility.

    Product
    Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/F ( I) BULB SYRINGE 60cc LIF (4) DRAPE UTILITY WIT APE LIF (I) SKIN MARKER W/RULER ( I) SUTURE BAG FLORAL LIF ( I) Y ANKAUER SUCTION TU
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Premium Urology Packs Due to Potential Sterility Loss

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

    Product
    PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) ABSORBENT TOWELS UF (1) MAYO STAND COVER REINFORCED UF (1) URINARY DRAINAGE BAG 2000ml ANTI-REFLUX UF (1) GOWN SURG. REINFORCED LARGE T/WRAP (1) UTILITY BOWL 32 OZ. (1) TUBE SUCTION CONNEC. W' X 12
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

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

    Customed, Inc. is recalling 20 lots of EO sterilized surgical gown packs because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

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

    Product
    GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER REINFORCED LIF ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (2) UTILITY BOWL 16 oz. LIF (1) GLASINE BAG PLAIN ( 1) SUTURE BAG FLORAL (4) DRAPE UTILITY WITH TAPE LIF ( 1) TABLE COVER REINFORCE
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls OB Packs Due to Potential Packaging Integrity Compromise

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

    Product
    OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/TAPE (1) PLASTIC BOWL W/Lid 70 oz. (1) EAR/ULCER SYRINGE 2oz. L/Free (1) UMBILICAL CORD CLAMP (1) BABY BEANNIES (1) PVP SCRUB 8" STICK SPO
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2014-09-10

    Customed Recalls Laminectomy Packs Due to Potential Packaging Integrity Issues

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

    Product
    LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" LIF ( I) SKIN MARKER INK W/8 LABEL ( I) CAUTERY TIP POLISHER LIF ( I) TUBE SUCTION CONNECT. W' X 12' LIF (6) DRAPE UTILITY W/TAPE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (2) UTILITY BOWL 16o
    Category
    Distribution
    2 states