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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 Device Recall 3M Micropore Paper Tape see related information
Date Initiated by Firm January 29, 2010
Date Posted April 20, 2010
Recall Status1 Terminated 3 on February 04, 2012
Recall Number Z-1416-2010
Recall Event ID 54640
Product Classification Surgical Tape - Product Code KGX
Product 3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 rolls / case.
Code Information 200901XI 200903XH 200904BK 200904YR 200906ER 200909CC 200909ES 200911NM 200911OJ 200902XH 200902XI 200902XU 200903YR 200904CA 200909EU 200812TR 200911FZ 
Recalling Firm/
3M Company / Medical Division
3M Center, Bldg 275-05-W-06
Saint Paul MN 55144
For Additional Information Contact Customer Helpline
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
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 2,664,800
Distribution Nationwide distribution, and Puerto Rico.
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.