ARTHROSCOPY PACK - (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) TUBE SUCTION CONNECT ~" X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1Y2 LIF (1) NEEDLE SPINAL ANESTH 18G X 3 Y2 LIF (1) PAD ABDOMINAL 8" X 7.5" LIF (2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds LIF (1) TIME OUT BEACON NON WOVEN LIF (1) NEEDLE HYPODERMIC 18G X 1 Y2 L/F (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) COVER TABLE 44" X 90" LIF (1) COUNTER NDLIBLADE 20C FOAM/MAG L/F (3) TOWELS ABSORBENT 15" X 20" LIF (1) BAG SUTURE FLORAL (1) SHEET DRAPE 70" X 1 00" SMS LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) SOLUTION SURGICAL DURAPREP 26ML LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE AAMI (1) TUR Y SET 81"2.1M REGULAR CLAM LIF LEVEL Ill TOWEL/WRAP LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" UF (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill LIF 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 900-740A, 1 lots: 140312021
- 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) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) TUBE SUCTION CONNECT ~" X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1Y2 LIF (1) NEEDLE SPINAL ANESTH 18G X 3 Y2 LIF (1) PAD ABDOMINAL 8" X 7.5" LIF (2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds LIF (1) TIME OUT BEACON NON WOVEN LIF (1) NEEDLE HYPODERMIC 18G X 1 Y2 L/F (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) COVER TABLE 44" X 90" LIF (1) COUNTER NDLIBLADE 20C FOAM/MAG L/F (3) TOWELS ABSORBENT 15" X 20" LIF (1) BAG SUTURE FLORAL (1) SHEET DRAPE 70" X 1 00" SMS LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) SOLUTION SURGICAL DURAPREP 26ML LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE AAMI (1) TUR Y SET 81"2.1M REGULAR CLAM LIF LEVEL Ill TOWEL/WRAP LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" UF (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product Codes/Lot Numbers:
Product code 900-740A, 1 lots: 140312021
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2345-2014
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.