3M Durapore Surgical Tape, Catalog Number 1538-118 recallZ-1633-2024 · 3M Company - Health Care Business · initiated Mar 20, 2024

Why it was recalled

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 root cause category: Error in labeling

What the company is doing

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

Recall details

Recall number

Z-1633-2024

Status

Open, Classified

Initiated by the company

Mar 20, 2024

Posted by the FDA

Apr 24, 2024

Recalling firm

3M Company - Health Care Business

Quantity

3,515,200 rolls

Product code

KGX

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.

Product description

3M Durapore Surgical Tape, Catalog Number 1538-118

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• 3M™ Durapore™ 1538-118

  3M Deutschland GmbH · Tape and bandage, adhesive
  1 recall0 reports