Reported Apr 20, 2022 · Ongoing
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
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 · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
- Lot codes and dates
- ROTAWIRE Drive Extra Support, 5 pack
- UPNH74939463005 Individual units within 5-pack are labeled as Single
- UPNH74939463001
- Batch numbers
27630467276327122770191027705926277497522774975427792970 27804244278051092780609127826574278265762785373627853738
- and 27862767 GTIN08714729996231
- Amount recalled
- 488 5-packs
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Pouch seals may be open, compromising sterility.
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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