Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) REF 89-10640, GTIN 50749756367740 (cs), 00749756367745 (unit), Lot Numbers: 58737945; b) REF 89-10901, GTIN 50749756380244 (cs), 00749756380249 (unit), Lot Numbers: 58820749; c) REF 89-1924, GTIN 50749756216864 (cs), 00749756216869 (unit), Lot Numbers: 58746227; d) REF 89-7133, GTIN 50749756736744 (cs), 00749756736749 (unit), Lot Numbers: 58789323; e) REF 89-9134, GTIN 50749756911332 (cs), 00749756911337 (unit), Lot Numbers: 58701336; f) REF 89-9478, GTIN 50749756926909 (cs), 00749756926904 (unit), Lot Numbers: 58738454
- 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:
- DeRoyal Industries Inc
- Reason for Recall:
- The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478
Product Codes/Lot Numbers:
a) REF 89-10640, GTIN 50749756367740 (cs), 00749756367745 (unit), Lot Numbers: 58737945; b) REF 89-10901, GTIN 50749756380244 (cs), 00749756380249 (unit), Lot Numbers: 58820749; c) REF 89-1924, GTIN 50749756216864 (cs), 00749756216869 (unit), Lot Numbers: 58746227; d) REF 89-7133, GTIN 50749756736744 (cs), 00749756736749 (unit), Lot Numbers: 58789323; e) REF 89-9134, GTIN 50749756911332 (cs), 00749756911337 (unit), Lot Numbers: 58701336; f) REF 89-9478, GTIN 50749756926909 (cs), 00749756926904 (unit), Lot Numbers: 58738454
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2088-2023
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