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Open, Classified

ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support

FDA Recall Z-0916-2022 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeMCX
Date Initiated2022-03-08
Product Quantity488 5-packs

Reason for Recall

Pouch seals may be open, compromising sterility.

Firm Action

US consignees were mailed an overnight delivery of the customer letter. OUS consignees will be contacted by letter delivery or email. Accounts are asked to return any unused affected devices to the recalling firm. The customer letter provides customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form indicating that they have received the field removal and followed the included instructions.

Root Cause

Process control

Distribution Pattern

Distribution in the US and territories, Japan, and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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