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Terminated

Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap

FDA Recall Z-0184-2020 · Posted None

Recalling FirmAndover Healthcare Inc.
Recall StatusTerminated
Product CodeFQM
Date Initiated2019-06-19
Date Terminated2020-09-09
Product Quantity1050 Cases

Reason for Recall

Incomplete packaging seal of sterile product

Firm Action

1. Identify and return all 3" and 4" sterile CoFlex products (Nl, LF2, AFD, MED) made between October 1, 2018 and June 14, 2019. 2. Discontinue the distribution and use of all 3" and 4" sterile Coflex product (Nl, LF2, AFD, MED) 3. Fax, phone, or email the acknowledgement of this recall notice to Fax: 978-499-0826, Email: [email protected], Phone:1(800)432-6686 For further information, questions, or concerns reach out to Andover Healthcare at: Phone: 1 (800) 432-6686, Monday through Friday 8 AM to 4:30 PM Eastern Time.

Root Cause

Packaging

Distribution Pattern

US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

Official Source

View FDA Recall →

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

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