PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625H40, PDP9626H40, PDP9631H40, PDP9715H15, PDP9715H40, PDP9733H16, PDP9861H40, PDP9865H40, XWPDP421H40, XWPDP423H40, XWPDP442H40, XWPDP443H16
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 10705031122574, 10705031047952, 10705031048232, 10705031048294, 10705031048300, 10705031048393, 10705031123786, 10705031048447, 10705031123854, 10705031123854, 10705031123861, 10705031203969, 10705031203983, 10705031204010, 10705031204034, 10705031048546, 10705031048553, 10705031124059, 10705031124677, 10705031124691, 10705031124707, 10705031124714, 10705031124752, 10705031124752, 10705031124769, 10705031124875, 10705031124899, 10705031123540, 10705031123564, 10705031123588, 10705031123595; Lot Numbers: RLMCKU, RLMEAL, RLMDST, RMMHLT, RJMMAC, SCMASA, RKMQDX, RKMBEB, SAMERU
- 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, LLC
- Reason for Recall:
- Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625H40, PDP9626H40, PDP9631H40, PDP9715H15, PDP9715H40, PDP9733H16, PDP9861H40, PDP9865H40, XWPDP421H40, XWPDP423H40, XWPDP442H40, XWPDP443H16
Product Codes/Lot Numbers:
UDI-DI: 10705031122574, 10705031047952, 10705031048232, 10705031048294, 10705031048300, 10705031048393, 10705031123786, 10705031048447, 10705031123854, 10705031123854, 10705031123861, 10705031203969, 10705031203983, 10705031204010, 10705031204034, 10705031048546, 10705031048553, 10705031124059, 10705031124677, 10705031124691, 10705031124707, 10705031124714, 10705031124752, 10705031124752, 10705031124769, 10705031124875, 10705031124899, 10705031123540, 10705031123564, 10705031123588, 10705031123595; Lot Numbers: RLMCKU, RLMEAL, RLMDST, RMMHLT, RJMMAC, SCMASA, RKMQDX, RKMBEB, SAMERU
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2616-2023
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.