FDA Medical Device Recalls (openFDA)
Andover Healthcare Inc.: Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
- Recall number
- Z-0181-2020
- Recalling firm
- Andover Healthcare Inc.
- Product
- Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap
- Status
- Terminated
- Initiated
- 2019-06-19
- Posted
- not on file
- Terminated
- 2020-09-09
- Reason
- Incomplete packaging seal of sterile product
- Root cause
- Packaging
- 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: orders@andoverhealthcare.com, 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.
- Quantity
- 330 Cases
- Distribution
- US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA
- Lot, serial or model codes
- Manufacturer's product or Catalog # 9300S Expiration Date: 01OCT2021-14JUN2022 LOT # CIOZJV, CI02SW, CI18YA, CI1FJ2
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQM
- Firm FEI
- 1220799
- Firm city
- Salisbury
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28