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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Durapore Advanced Surgical Tape

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  Class 2 Device Recall 3M Durapore Advanced Surgical Tape see related information
Date Initiated by Firm November 21, 2019
Create Date December 20, 2019
Recall Status1 Terminated 3 on April 23, 2021
Recall Number Z-0719-2020
Recall Event ID 84376
Product Classification Tape and bandage, adhesive - Product Code KGX
Product 3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
Code Information All lots
Recalling Firm/
Manufacturer		 3M Company - Health Care Business
3m Center 2510 Conway Ave , B# 275-5-W-6
Saint Paul MN 55144-0001
For Additional Information Contact Customer Helpline
800-228-3957
Manufacturer Reason
for Recall		 While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical Tape to continuous high moisture clinical applications has not fully met all of 3M s performance expectations. This use environment may cause tape bond failure, leading the tape to not perform as intended. Further, the tape fibers may fray which could be accidentally ingested or aspirated.
FDA Determined
Cause 2		 Device Design
Action The firm initiated the recall by letter on 11/20/2019. The letter explained the failures seen and requested the following actions be taken: 1. Immediately cease use of the product and quarantine it for destruction/disposal. 2. Complete the attached Customer Acknowledgement Form with the following: - Acknowledge that you have read and understood this letter whether or not you have any 3M" Durapore" Advanced Surgical Tape in stock at your facility; and - Indicate if you have any product in stock and dispose of this material per facility policy. - Email the completed form to 3Mhealthcare@montage72.com 3. If there are clinical questions, contact Kimberly Schommer, RN, BSN via the 3M Health Care Customer Helpline at 1-800-228-3957.
Quantity in Commerce 470,954 rolls
Distribution Nationwide, Canada, Germany, France, Switzerland, Denmark
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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