Class 2 Device Recall 3M Micropore Surgical Tape

• Date Initiated by Firm: January 29, 2010
• Date Posted: April 20, 2010
• Recall Status: Terminated on February 04, 2012
• Recall Number: Z-1413-2010
• Recall Event ID: 54640
• Product Classification: Surgical Tape - Product Code KGX
• Product: 3M Micropore Single Use Rolls, Surgical Tape, REF 1530S-1, 1 in x 1-1/2 yd.
• Code Information: Lot numbers containing "2014" and lot numbers beginning with "2015-01" followed by two-character letters: AA, AB, AC, AD, AE, AF, AH, AI, AL, AN, BW.
• Recalling Firm/ Manufacturer: 3M Company / Medical Division; 3M Center, Bldg 275-05-W-06; Saint Paul MN 55144
• 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: 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: 165,826 boxes, 100 rolls per box (16,582,600 rolls)
• 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.