Andover Healthcare Inc. Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Brand
Andover Healthcare Inc.
Lot Codes / Batch Numbers
Manufacturer's product or Catalog # 5400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0PVV, CI0V78, CI0X0B, CI16CG, CI17BB, CI18KB, CI18Y7, CI1E36, CI1JCE
Products Sold
Manufacturer's product or Catalog # 5400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0PVV, CI0V78, CI0X0B, CI16CG, CI17BB, CI18KB, CI18Y7, CI1E36, CI1JCE
Andover Healthcare Inc. is recalling Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap due to Incomplete packaging seal of sterile product. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incomplete packaging seal of sterile product
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026