PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027
- 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:
- Ethicon, Inc.
- Reason for Recall:
- knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery
Product Codes/Lot Numbers:
UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0480-2023
Related Recalls
Potential for barb non-engagement.
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.