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 HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 (1) NEEDLE HYPODERMIC 22G X 1 (1) SYRINGE 30cc W/0 NEEDLE LUER LOCK (1) SCALPEL W/HANDLE 11 (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (1) RULER (3) Pr. GLOVESURG 8 DERMA PRENE POWDER FREE (1) BANDAGE ELASTIC KNIT STD 10yds (1) BANDAGE ESMARK 6 X 9yds (8) TOWELS CLOTH HUCK BLUE (1) U - DRAPE 60 X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) BOWL UTILITY 16oz. (1) COVER TABLE REINFORCED 50 X 90 (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL REINFORCED X-LARGE T/WRAP (2) TOWELS ABSORBENT 15X 20 (1) STOCKINETTE IMPERV 12 X 48 (2) BAG PLASTIC 6 X 12 (1) KNEE ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (2) LITE GLOVE Product Usage: 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: Code 900-2718: 3 lots 113026299 113068033 113078728
- 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:
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 HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 (1) NEEDLE HYPODERMIC 22G X 1 (1) SYRINGE 30cc W/0 NEEDLE LUER LOCK (1) SCALPEL W/HANDLE 11 (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (1) RULER (3) Pr. GLOVESURG 8 DERMA PRENE POWDER FREE (1) BANDAGE ELASTIC KNIT STD 10yds (1) BANDAGE ESMARK 6 X 9yds (8) TOWELS CLOTH HUCK BLUE (1) U - DRAPE 60 X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) BOWL UTILITY 16oz. (1) COVER TABLE REINFORCED 50 X 90 (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL REINFORCED X-LARGE T/WRAP (2) TOWELS ABSORBENT 15X 20 (1) STOCKINETTE IMPERV 12 X 48 (2) BAG PLASTIC 6 X 12 (1) KNEE ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product Codes/Lot Numbers:
Code 900-2718: 3 lots 113026299 113068033 113078728
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2499-2014
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.