Class 2 Device Recall 3M Durapore Surgical Tape

• Date Initiated by Firm: March 20, 2024
• Date Posted: April 24, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1633-2024
• Recall Event ID: 94259
• Product Classification: Tape and bandage, adhesive - Product Code KGX
• Product: 3M Durapore Surgical Tape, Catalog Number 1538-118
• Code Information: UDI/DI 50707387793208, Lot Codes: 33DER3, 33DTMA, 33DTPN, 33EDDE, 33ETFA, 33ETHX, 33FDHA, 33FDYN, 33FE9D, 33FEY6, 33FTLA, 33FW6E, 33FWPC, 33JE7T, 33JEFK, 33JENC, 33JYPX, 33JYW5, 33K3EJ, 33KPWT, 33KT6R, 33KT8F, 33LJWC, 33LK5M, 33LLEY, 33LLPT, 33LM6R, 33LMET, 33LMX3, 33N56W, 33N5K4, 33N5TC, 33NF36, 33NF6A, 33NY98, 33NYP9, 33P37P, 33PKLN, 33PL6J, 33PMFA, 33R35M, 33R3P6, 33RMNF, 33RNP4, 33TL39, 33TL8F, 33TLF4, 33TN55, 33WEA8, 33WEHJ, 33WERX, 33WF5P, 33WFD5
• Recalling Firm/ Manufacturer: 3M Company - Health Care Business; 3m Center 2510 Conway Ave; Bldg 275-5w-06; Saint Paul MN 55144-0001
• For Additional Information Contact: Liisa Sheldrick; 519-675-4082
• Manufacturer Reason for Recall: Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled with a shelf life of 5 years, rather than 3 years.
• FDA Determined Cause: Error in labeling
• Action: 3M issued an URGENT: Voluntary Product Recall to its consignees on 03/20/2024 via email and USPS certified mail. The notice explained the issue and requested the following: Identify all affected lots in inventory (bulk) or built into kits, including kits that have been distributed. Bulk inventory: use Appendix 1 to determine the correct expiration dates to use when building kits. a. If the affected product in inventory is within the correct expiration date for the affected product correct the expiration date on the bulk package label and ensure future kits reflect the correct expiration date for the 3M affected product. b. If the affected product in inventory exceeds the correct expiration date, please destroy per facility policy. 3. Kits: Review the affected 3M lots that have been built into kits. Using Appendix 1 to determine the correct expiration date for each lot, assess if the expiration date of the kit is within the correct expiration date for the affected product. a. If the kit was labeled within the correct expiration date for the affected product, no action is required for kits in inventory nor for any kits you have distributed. b. If the kit was labeled with an expiration date exceeding the correct expiration date of the affected product, action is required. i. Kit inventory: Take action to rectify the expiration date of the kit according to the correct expiration date of the affected product or destroy the kits per facility policy. ii. Kits that have been distributed: If you have distributed kits labeled with an expiration date exceeding the correct expiration date of the affected product, please notify the impacted customers of this issue and FDA of your intent to recall/correct the affected kits. To request replacement product for the destroyed 3M Durapore Surgical Tape, Catalog Number 1538-118 product, contact 3M Health Care Customer Helpline to submit all replacement requests by calling 1-800-228-3957, option #7, or by email to 3MF
• Quantity in Commerce: 3,515,200 rolls
• Distribution: Worldwide distribution - US Nationwide in the states of TX, NY, NH, AZ, NC, CA, IL, GA, VA, MD, FL, and the country of Canada.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.