Reported Dec 21, 2022 · Ongoing
PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue…
Ethicon, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon, Inc. · Us Highway 22 West · Somerville, NJ · 08876
Is this the product you have?
- PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0
- S/A CT-1 Product CodeZ340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery
- Lot codes and dates
- UDI-DI
10705031060623 (individual unit)30705031060634 (sales
- unit box) LotSCMSHK Exp
- Date
February 282027
- UDI-DI
- Amount recalled
- 7,560 eaches
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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