Reported Sep 27, 2023 · Ongoing
PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50,…
Ethicon, LLC
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, LLC · 475 Calle C Ste 401 · Guaynabo, PR · 00969-4292
Is this the product you have?
- 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
- Lot codes and dates
- UDI-DI
10705031122574107050310479521070503104823210705031048294107050310483001070503104839310705031123786107050310484471070503112385410705031123854107050311238611070503120396910705031203983107050312040101070503120403410705031048546107050310485531070503112405910705031124677107050311246911070503112470710705031124714107050311247521070503112475210705031124769107050311248751070503112489910705031123540107050311235641070503112358810705031123595
- Lot NumbersRLMCKU, RLMEAL, RLMDST, RMMHLT, RJMMAC, SCMASA, RKMQDX, RKMBEB, SAMERU
- UDI-DI
- Amount recalled
- 868,363 total units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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