Recall Z-0916-2022— Boston Scientific Corporation

Name: FDA recall Z-0916-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-08

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2022-03-08. FDA's recall record names no specific 510(k) clearance for this event. Product: ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support. Reason: Pouch seals may be open, compromising sterility..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-03-08
Firm location: Maple Grove, MN, United States

Product description

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support

Reason for recall

Pouch seals may be open, compromising sterility.

Data sourced from openFDA. This site is unofficial and independent of the FDA.