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Class 2 Device Recall Sterile CoFlex |
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Date Initiated by Firm |
June 19, 2019 |
Create Date |
October 23, 2019 |
Recall Status1 |
Terminated 3 on September 09, 2020 |
Recall Number |
Z-0182-2020 |
Recall Event ID |
83239 |
Product Classification |
Bandage, elastic - Product Code FQM
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Product |
Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap |
Code Information |
Manufacturer's product or Catalog # 9400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI147V, CI15F1, CI17B9, CI18Y0, CI1FJ3, CI1JCF |
Recalling Firm/ Manufacturer |
Andover Healthcare Inc. 9 Fanaras Dr Salisbury MA 01952-1444
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For Additional Information Contact |
Nathan Yetton 978-465-0044
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Manufacturer Reason for Recall |
Incomplete packaging seal of sterile product
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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 |
1759 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
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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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