FDA recall Z-0916-2022
Boston Scientific Corporation · Class II · device
Product
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Reason for recall
Pouch seals may be open, compromising sterility.
Distribution
Distribution in the US and territories, Japan, and Canada
Key facts
- Status
- Ongoing
- Initiation date
- 2022-03-08
- Report date
- 2022-04-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Maple Grove, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0916-2022