Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Class I - DangerousWhat Should You Do?
- Check if you have this product: (1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249.
- 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:
- ROi CPS LLC
- Reason for Recall:
- Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Product Codes/Lot Numbers:
(1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249.
Distribution:
Distributed in: MO
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1407-2022
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