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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile CoFlex

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  Class 2 Device Recall Sterile CoFlex see related information
Date Initiated by Firm June 19, 2019
Create Date October 23, 2019
Recall Status1 Terminated 3 on September 09, 2020
Recall Number Z-0180-2020
Recall Event ID 83239
Product Classification Bandage, elastic - Product Code FQM
Product Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Code Information Manufacturer's product or Catalog # 5400S  Expiration Date: 01OCT2021-14JUN2022 Lot # CI0PVV, CI0V78, CI0X0B, CI16CG, CI17BB, CI18KB, CI18Y7, CI1E36, CI1JCE   
Recalling Firm/
Manufacturer		 Andover Healthcare Inc.
9 Fanaras Dr
Salisbury MA 01952-1444
For Additional Information Contact Nathan Yetton
978-465-0044
Manufacturer Reason
for Recall		 Incomplete packaging seal of sterile product
FDA Determined
Cause 2		 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 in Commerce 8500 Cases
Distribution US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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