CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) 89-7935.11, Lot codes: 48285959 exp 12/21/2022 b) 89-7935.12, Lot codes: 49057260 exp 5/1/2023, 49239952 exp 4/1/2023, 49481001 exp 6/1/2023, 49603726 exp 8/1/2023, 49864125 exp 7/1/2021 c) 89-7935.13, Lot codes: 50404644 exp 11/1/2021, 50698398 exp 11/1/2023 d) 89-7935.14, Lot codes: 5125317 exp 6/1/2022 e) 89-7935.15, Lot codes: 51305461 exp 2/1/2024, 51983318 exp 2/1/2024 f) 89-7935.16, Lot codes: 53324463 exp 12/1/2024
- 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:
- Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.
Product Codes/Lot Numbers:
a) 89-7935.11, Lot codes: 48285959 exp 12/21/2022 b) 89-7935.12, Lot codes: 49057260 exp 5/1/2023, 49239952 exp 4/1/2023, 49481001 exp 6/1/2023, 49603726 exp 8/1/2023, 49864125 exp 7/1/2021 c) 89-7935.13, Lot codes: 50404644 exp 11/1/2021, 50698398 exp 11/1/2023 d) 89-7935.14, Lot codes: 5125317 exp 6/1/2022 e) 89-7935.15, Lot codes: 51305461 exp 2/1/2024, 51983318 exp 2/1/2024 f) 89-7935.16, Lot codes: 53324463 exp 12/1/2024
Distribution:
Distributed in: OK, MI, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1138-2021
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