Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: N/A Model Number Lot # US1638: A1K0289Y, A1K0291Y, US1638 A1K0283Y ; US1756: A2E0454Y
- 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:
- Covidien, LP
- Reason for Recall:
- Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
Product Codes/Lot Numbers:
GTIN: N/A Model Number Lot # US1638: A1K0289Y, A1K0291Y, US1638 A1K0283Y ; US1756: A2E0454Y
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1182-2023
Related Recalls
Temperature probe devices lack FDA clearance.
Due to customer complaint regarding incorrect display box labeling.
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.