PlainRecalls
FDA Devices Moderate Class II Ongoing

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support

Reported: April 20, 2022 Initiated: March 8, 2022 #Z-0916-2022

Product Description

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support

Reason for Recall

Pouch seals may be open, compromising sterility.

Details

Units Affected
488 5-packs
Distribution
Distribution in the US and territories, Japan, and Canada
Location
Maple Grove, MN

Frequently Asked Questions

What product was recalled?
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support. Recalled by Boston Scientific Corporation. Units affected: 488 5-packs.
Why was this product recalled?
Pouch seals may be open, compromising sterility.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 20, 2022. Severity: Moderate. Recall number: Z-0916-2022.