3M Urological Drape: Adhesive Liner Removal Issues and Skin Injuries
3M has recalled 17,200 units of urological drapes due to adhesive liner removal difficulty and reported skin injuries. The affected drapes may become unusable in surgical settings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II medical device with documented reports of adhesive-related skin injuries and product defects that render the drapes unusable, meeting the rubric criteria for significant injury reports.
Plain-English summary
3M Healthcare Business is recalling 17,200 units of Steri-Drape Urological Drapes (REF 1071) due to issues with the adhesive component. The liner on the adhesive is difficult to remove without damaging the product, potentially rendering it unusable for surgical procedures.
Additionally, 3M has documented an increase in reported skin injuries related to the adhesive on these affected lots. Healthcare facilities and providers should stop using the affected drapes and contact 3M or their supplier for replacement or refund instructions.
Affected lot numbers are: 33HJ3C, 33HTFH, 33J9CT, 33JED6, 33JJHN, 33K968, and 33KTRH. The product was distributed worldwide.
The recalled product
- Product
- 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
- Manufacturer
- 3M Healthcare Business
- Category
- Medical Device — Surgical Drape
- Affected units
- 17,200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- UDI/DI (01)30707387018741
- Lot numbers: 33HJ3C
- 33HTFH
- 33J9CT
- 33JED6
- 33JJHN
- 33K968
- 33KTRH
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 18 recalled by 3M Healthcare Business under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
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