Reported May 16, 2018 · Terminated
Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or…
Boston Scientific Corporation
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: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
- Lot codes and dates
- UDI08714729257622
- Batch numbers
1781754719050231206390261792541019225758207175241813920019335465210817531836373719437994212587811861571419698427213862111882658719983956203414491895568920341449
- Amount recalled
- 4,144
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
Why it was recalled
Potential for Capio sutures to break and /or detach.
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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