Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap
This recall has been terminated (originally issued June 19, 2019).
- Company
- Andover Healthcare Inc.
- Recall Initiated
- June 19, 2019
- Terminated
- September 9, 2020
- Recall Number
- Z-0183-2020
- Quantity
- 269 Cases
- Firm Location
- Salisbury, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Incomplete packaging seal of sterile product
Distribution
US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA
Lot / Code Info
Manufacturer's product or Catalog # 7300S Expiration Date: 01OCT2021-14JUN2022 Lot : CI10LN
Root Cause
Packaging
Action Taken
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.