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

1–25 of 233

  • CriticalFDA (Devices)··2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

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

    Product
    Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (2) STRIPS TAPE 24" X 4" (1) SUTURE BAG FLORAL (1) SHEET SPLIT W/ADHESIVE 1 08" X…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparoscopy Gyn Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 1,136 units of Laparoscopy Gyn Packs across 34 lots because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY GYN PACK - - (1) BLADE SURGICAL #11 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWEL 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) TOWEL CLOTH HUCK BLUE (1) BLADE SURGICAL #15 CARBON STEEL (2) UTILITY BOWL 16oz (1) UTILITY…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Angiography Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 1,305 units of angiography packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ANGIOGRAPHY PACK - ( 1) FEMORAL ANGlO. DRAPE WITH POUCH (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 21G X 1% ( 1) TABLE COVER REINFORCED 44" X 78" LIF (30) GAUZE SPONGES 4" X 4" 12PLY ( 1) GOWN IMPERVIOUS REINFORCED LARGE SMS ( 1) GOWN LARGE NON…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,300 laparotomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 41 II X 58" SMS L/F ( 1) TABLE COVER 50" X 90" LIF ( 1) SOLUTION SURGICAL DURAPREP 26ML…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Premium Laparotomy Packs Due to Packaging Integrity Concerns

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

    Product
    PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) SPONGE LAP…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Basic Pack 1 Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Basic Pack 1 surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE UTILITY WffAPE (2) TOWELS ABSORBENT 15" X 20" (1) SUTURE BAG FLORAL (1) DRAPE SHEET 42" X 57" SMS (1) SHEET :X 57" X 63" REINFORCED SMS (1) MAYO STAND COVER REINFORCED Product Usage…
    Category
    Distribution
    2 states
  • SevereFDA (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
  • CriticalFDA (Devices)··2014-09-10

    Customed Recalls Major Lap Packs Due to Potential Packaging Integrity Issues

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

    Product
    MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILITY BOWL 32oz (1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER (1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE (2)…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 208 units of surgical packs for knee and hip replacements because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL (2) SCALPEL WEIGHTED SAFETY # I0 (I) STOCKrNETTE…
    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…
    Category
    Distribution
    2 states
  • SevereFDA (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…
    Category
    Distribution
    2 states
  • CriticalFDA (Devices)··2014-09-10

    Customed Recalls Vaginal Procedure Packs Due to Packaging Integrity Concerns

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

    Product
    VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (1) COVER TABLE REINF 50" X 90" LIF (1) TUBE…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 420 units of EO-sterilized Cesarean Packs because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.

    Product
    CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,620 units 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 (1 0) GAUZE SPONGES 4" X 4" 16PL Y (1) TUBE SUCTION CONNECTING X" X 12' LIF (1) IMP. STOCKINETTE (1) SURGICAL BLADE #11 STAINLESS STEEL (1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~ (1) SYRINGE Sec WITH NEEDLE 21G X 1 ~…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 21 lots of Laparoscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE BANDAGE%" X 3" ST. LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (2) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE LASER CAMERA…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls AV Fistula Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV (1) DRAPE SHEET 42" X 57" SMS (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) TUBE…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Premium Arthroscopy Packs Due to Packaging Integrity Concerns

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

    Product
    PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF (1) IMPERVIOUS STOCKINETTE (3) STRIPS TAPE 24" X 4" (1) DRAPE U WITH TAPE SPLIT (2) TOWELS ABSORBENT 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) GOW SURG. REINFORCED LARGE…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Breast Surgical Packs Due to Potential Sterility Loss

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

    Product
    Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII (4) TOWELS ABSORBENT 15" X 20" LIF (1) PENCIL CAUTERY PUSH BOTTOM LIF (1) SYRINGE 60ML LUER LOCK WITHOUT NEEDLE L/F (1) TUBE SUCTION CONNECT X" X 12' LIF…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Open Heart Surgical Trays Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Open Heart Surgical Trays because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53" X 77" LIF ( 1) MAYO STAND COVER REINFORCED LIF (7) DRAPE UTILITY WITH TAPE L/F (8) HUCK CLOTH TOWELS WHITE L/F (20) HUCK CLOTH TOWELS BLUE LIF (1) MAYO TRAY LARGE…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Minor Laparotomy Packs Due to Packaging Integrity Concerns

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

    Product
    MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) COUNTER NEEDLE & BLADE 10C…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Carpal Tunnel Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF (1) NEEDLE HYPODERMIC 18G X 1 % LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BOWL UTILITY QUART 32oz. (2) SHEET DRAPE 41" X 58" SMS LIF (2) TOWELS ABSORBENT 15" X 20" LIF (1) BANDAGE GAUZE STRETCH…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Orthopedic Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20" LIF (1) COVER MAYO STAND REINFORCED L/F ( 1) U- DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF (1) DRAPE % ECONOMY 53" X 77" LIF (4) DRAPE UTILITY WIT APE LIF (1) BAG SUTURE FLORAL LIF (1) SHEET…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Tummy Tuck Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER (1) NEEDLE HYPODERMIC 22G X 1 Y2 (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) COUNTER NEEDLE & BLADE…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Tummy Tuck Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Tummy Tuck Pack-BOD surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (2) TOWELS ABSORBENT 15 X 20 (1) PENCIL CAUTERY PUSH BOTTOM (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (2) SKIN…
    Category
    Distribution
    2 states
  • CriticalFDA (Devices)··2014-09-10

    Customed Recalls Laparoscopy Colorectal Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 280 units of Laparoscopy Colorectal Surgical Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11…
    Category
    Distribution
    2 states