Reported May 16, 2018 · Terminated
Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open…
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 Open Access Box 4 (Capio OPC); Model #M0068311251. 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
- UDI08714729257615
- Batch numbers
65 of 65 codes
177368841874313719980158177439151874475820088658177463531883192120146415177486951895218520151917177586031895632920225741177630241896034520225743177919301904699420341445179706781904699620341447181296931904699820560166181341471917328520639024181352711922575620706637182291781932947920711254182818171943799620713128182862951944273920822293183570191956031620833214183622441964604320834317184304111964622220838382184882881965904221069563186057541982476721081751186060041983526721258659
- Amount recalled
- 21,051
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.
Want the full recall guide?
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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