Recall Z-0179-2020 ยท FQM Bandage, Elastic
Andover Healthcare Inc.
Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.
| Date | Jun 19, 2019 |
| Status | Terminated |
| 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 | 1798 Cases |
| Distribution | US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.