Summary
The FDA issued a Class II for 3M Durapore Surgical Tape, Catalog Number 1538-118 by 3M Company - Health Care Business. Reason: 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..
Details
Source
Device Recall
External ID
Z-1633-2024
Action Date
2024-05-01
Status
Ongoing
Category
device
Product Description
3M Durapore Surgical Tape, Catalog Number 1538-118
Lot/Code Info: 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
Quantity Affected: 3,515,200 rolls
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-20
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
3M Company - Health Care Business has 13 FDA actions in our database, including 13 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (3M Company - Health Care Business) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does 3M Company - Health Care Business have FDA actions?
3M Company - Health Care Business has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1633-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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