FDA-Device2022-04-20Class II

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support

Boston Scientific Corporation
Hazard

Pouch seals may be open, compromising sterility.

Sold states
Distribution in the US and territories, Japan, and Canada
Affected count
488 5-packs
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0916-2022

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