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) TOWELS ABSORBENT 15" X 20" LIF (2) CONTAINER SPECIMEN 4oz. WITH LID & LABEL (1) BABY BLANKET IMP. POLY ABS. LIF (1) NEEDLE HYPODERMIC 20G X 1%'' (10) GAUZE SPONGES 4" X 4" 16PLY (1) BLADE SURGICAL #11 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) IMPERVIOUS STOCKINETTE (1) SHEET DRAPE 42" X 55" LIF (1) SUTURE BAG FLORAL LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) MAYO STAND COVER REINFORCED LIF (2) GOWN IMPERVIOUS REINFORCED SMS LARGE (4) STRIPS TAPE (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) GAUZE KERLIX 4.5 X 4.1 YO 6PL Y (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL & WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product code 900-1042, 12 lots: 113026163 113036737 113046994 113057378 113078232 113078669 113089153 113109704 131110065 131110610 140111137 140312045
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Customed, Inc
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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) TOWELS ABSORBENT 15" X 20" LIF (2) CONTAINER SPECIMEN 4oz. WITH LID & LABEL (1) BABY BLANKET IMP. POLY ABS. LIF (1) NEEDLE HYPODERMIC 20G X 1%'' (10) GAUZE SPONGES 4" X 4" 16PLY (1) BLADE SURGICAL #11 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) IMPERVIOUS STOCKINETTE (1) SHEET DRAPE 42" X 55" LIF (1) SUTURE BAG FLORAL LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) MAYO STAND COVER REINFORCED LIF (2) GOWN IMPERVIOUS REINFORCED SMS LARGE (4) STRIPS TAPE (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) GAUZE KERLIX 4.5 X 4.1 YO 6PL Y (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL & WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product Codes/Lot Numbers:
Product code 900-1042, 12 lots: 113026163 113036737 113046994 113057378 113078232 113078669 113089153 113109704 131110065 131110610 140111137 140312045
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2368-2014
Related Recalls
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.