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

  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Open Heart Surgical Tray Packs Due to Packaging Integrity Concerns

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

    Product
    OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F (3) TOWEL ABSORBENT 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SPLIT SHEET BILATERAL 84" X 80" (12) % SHEET 60" X 77" DRAPE…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Curation Kits Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 16 lots of Curation Kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP APPLICATOR (4) PVP PREP SOLUTION 1 oz (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) EXAM GLOVES MEDIUM (1) WRAPPER 24" X 24" UF (1) PACKING TRAY EO sterilized surgical convenient packs…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Face Pack BOD Due to Potential Packaging Integrity Issues

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

    Product
    Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWELS ABSORBENT 15" X 20" (1 ) DRAPE INSTRUMENT MAGNETIC 10" X 16" (1 ) TRAY HALF DEEP (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1 ) SHEET ENT SPLIT…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Shoulder Arthroscopy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 1,707 units of Shoulder Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2) DRAPE SHEET 70" X 100" (1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST. (1) STOCKINETTE 6 X 48" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (1) SCALPEL…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Tummy Tuck Packs Due to Potential Packaging Compromise

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

    Product
    Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6 (6) TOWEL CLOTH HUCK…
    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) DRAPE T LAPAROTOMY (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) TOWELS ABSORBENT 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE (1)…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparoscopy Chole Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 2,192 units of Laparoscopy Chole Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W' X 4" LIF ( 1) TABLE COVER REINFORCED 50" X 90" LIF ( 1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" LIF (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) GOWN XL SMS IMPERVIOUS REINFORCED L/F (5) TOWELS ABSORBENT 15"…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    Plastic Pack Customed, code 900-2582 (1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF LGE TMJRAP LIF (1) MAYO STAND COVER REINF LIF (1) TABLE COVER REINF 50" X 90" LIF (4) (1) PVP PAINT 8" STICK SPONGE (2) DRAPESHEET 41X A¿MED LIF (3) TOWELS ABSORBENT 15 X 20 LIF…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Universal Pack II Surgical Packs Due to Packaging Integrity Concerns

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

    Product
    Universal Pack II (2) Customed 900-2509 (1) MAYO STAND COVER REINFORCED (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTTOM ABSORBENT REINFORCED 71" X 62" STD SMS WITH TAPE (1) DRAPE TOP W/ADHESIVE 1 08" X 50" STD SMS (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 50" X…
    Category
    Distribution
    2 states
  • SevereFDA (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…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed O.B. Pack Recalled for Potential Packaging Integrity Compromise

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

    Product
    Customed O.B. Pack convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord clamp, wash basin, baby blankets, table cover, gauze sponge, syringe 10CC w/o needle & 10CC with needle, feeding tube, drape, legging with…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparoscopy Chole Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 1,671 units of Laparoscopy Chole Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWELS 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SURGICAL DURAPREP SOLUTION 26ml LIF (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. (1) DRAPE LASER CAMERA W/EL 6" X 96" (1)…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Colorectal Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 626 units of Laparoscopia Colorectal Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4) DRAPE UTILITY WITH TAPE (1) TOWELS ABSORBENT 15" X 20" (2) LEGGINS W/7" CUFF 30" X 42" (1) BLADE SURGICAL #15 STAINLESS STEEL (1) BLADE SURGICAL #11 STAINLESS STEEL (1) GOWN…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 154 units of Laparoscopy packs (Code 900-3178) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG REINFORCED XL EXTRA LONG LEVEL IV (4) TOWEL ABSORBENT 15" X 20" LIF…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparoscopy Premium Packs Due to Packaging Integrity Concerns

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

    Product
    LAPAROSCOPY PREMIUM PACK - (1) TABLE COVER REINFORCED 50" x 90" UF (4) TOWEL ABSORBENT 15" x 20" UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) DRAPE LASER CAMERA W/EL UF (1) TROCAR ENDO.XCEL DILATING TIP (KSLT) (1) APPLIER CLIP 5MM (3) GOWN XLGE SMS IMPERV. REINFORCED…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 3,066 units of EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF (2) DRAPE SHEET 41 " X 58" SMS (1) BANDAGE GAUZE 4" STRETCH (1) NEEDLE HYPODERMIC 25G X 5/8" (1) STOCKINETTE 6" X 48" LIF (2) CLOTH HUCK…
    Category
    Distribution
    2 states
  • CriticalFDA (Devices)··2014-09-10

    Customed Angiodrape Pack Recalled for Potential Packaging Integrity Issues

    Customed, Inc. is recalling 1,536 units of Angiodrape Packs due to potential packaging integrity issues that could compromise sterility and risk patient injury.

    Product
    Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth huck towel,iodine povidone,applicator sponge,towel…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Laparoscopy Chole Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 843 units of Laparoscopy Chole Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2) SHEET DRAPE 42" X 57" SMS (1) TUBE SUCTION CONNECT. %" X12' LIF (1) SURGICAL BLADE #10 STAINLESS STEEL (1) TABLE COVER REINFORCED 44" X 78" LIF (1) DRAPE LAPAROSC. ABD 102" X 122" X 78" WITH…
    Category
    Distribution
    2 states
  • SevereFDA (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…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Major Laparotomy Pack Recalled for Potential Sterility Loss

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

    Product
    Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove, gauze/sponges, drape, surgical blades, utility bowls, towels, tube suction, cautery tip, gown, and labels. EO…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Foley Catheter Kits Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 27 lots of Foley Catheter Kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM (1) TOWEL 3PLY POLY 17" X 18" (2) SWABSTICK DRY COTTON (1) DRAPE 4" FENESTRATED 18" X 26" (1) CATHETER…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls Neuro Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling TRAATEK NEURO PACK surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) CAUTERY TIP POLISHER LIF (8) TOWEL CLOTH HUCK (BLUE) ( 1) BULB SYRINGE 60cc LIF ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE (2) LITE GLOVE ( 1) TUBE SUCTION CONNECT. Y.."…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Recalls ACDFPACK Surgical Center Packs Due to Packaging Integrity Concerns

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

    Product
    ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF (3) GOWN SOFT SMS STD XL SET IN SLEEVE LIF (3) TOWELS ABSORBEN 15" X 20" UF (1) TABLE COVER REINFORCED 50" X 90" L/F (1)…
    Category
    Distribution
    2 states
  • SevereFDA (Devices)··2014-09-10

    Customed Liposuction Surgical Packs Recalled for Packaging Integrity Concerns

    Customed, Inc. is recalling Liposuction Pack BOD units due to potential packaging integrity issues that could compromise sterility and lead to patient injury.

    Product
    Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) LITE GLOVES LIF (2) TOWEL ABSORBENT 15" X 20" L/F (1) NEEDLE HYPODERMIC 27G X 1 %" LIF (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED L/F (1) PVP SCRUB…
    Category
    Distribution
    2 states
  • SevereFDA (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 - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I) UTILITY BOWL 32oz ( I) GOWN IMP. REINFORCED XL SMS AAMI Ill (2) NEEDLE & BLADE COUNTER I OC MAG/CLEAR ( I) DRAPE LAPAROT ABDOM WITH POUCH (2) TOWELS ABSORBENT 15" x 20" ( I) TIME OUT…
    Category
    Distribution
    2 states