Reported Jun 21, 2017 · Terminated
Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
Medtronic
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: Medtronic · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- Sutures
- BIOSYNBIOSYN 4/0 18" VIOLET CV-25 DT
- Item NumberGMJ34M
- Lot codes and dates
- BIOSYN* 4/0 18" VIOLET CV-25 DT D4K0010X
- Amount recalled
- 478,465 (total for all products)
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
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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