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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Micropore Paper Tape

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 Class 2 Recall
3M Micropore Paper Tape
see related information
Date Posted April 20, 2010
Recall Status1 Terminated on February 04, 2012
Recall Number Z-1420-2010
Recall Event ID 54640
Product Classification Tape And Bandage, Adhesive - Product Code KGX
Product 3M Micropore Paper Tape, Cat. No. 1530-336, 3 in x 36 in., 240 rolls / case.
Code Information 200902YK 200903AR 200904YR 200908JY 200909LA 200912OU 201001RN
Recalling Firm/
Manufacturer
3M Company / Medical Division
3M Center, Bldg 275-05-W-06
Saint Paul, Minnesota 55144
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Customer Helpline
800-228-3957
Manufacturer Reason
for Recall
Reduced adhesion: Micropore Surgical Tape for use as the primary securement device for 1) dialysis needles used to access A-V fistulas or grafts; or 2) pressure dressings used after dialysis treatments. If the tape does not perform, the dialysis needle may loosen and could then dislodge. In the interim, please offer 3M Micropore Surgical Tape, 1 inch x 10 yard rolls (CAT #1530-1) as a substitutio
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action An Urgent Medical Device Recall letter was sent to 3M customers beginning 01/29/2010. The letter described the issue, asked distributors to check existing inventory, quarantine affected lots. Distributors were asked to notify their customers and end-users (3M has provided example letters and return forms to facilitate). End users can return product either to the distributor or contact 3M directly. A Product Recall Form is asked to be faxed back to 3M. A second 3M "Urgent Medical Device Recall" letter dated February 22, 2010 was sent to customers. This letter informed the cusotmers that 3M was expanding the recall to include bulk-packaged rolls of Micropore Surgical Tape. The letter addressed to "Valued Kit manufacturer" described the problem and the product, provided instrucitions for "Action Requried by the Kit Manufacturer", "Action Requried by the Kit Manufacturer to the End-User", and "Action Required for Future Tape Orders from 3M". A Product Recall Form is aked to be faxed back to 3M.
Quantity in Commerce 15,360 rolls
Distribution Nationwide distribution, and Puerto Rico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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