Reported Jun 26, 2024 · Ongoing
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in…
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. · 1000 Route 202 · Raritan, NJ · 08869-1425
Is this the product you have?
- PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable
- PRODUCT CODEPDP304H PDP316H PDP341H
- Lot codes and dates
- GTIN10705031047976 10705031048027 10705031048119 PRODUCT CODE PRODUCT LOTS PDP304H TLMJLZ PDP316H UAMKDC PDP341H UBMCZA
- Amount recalled
- 45828 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
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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