The Recall Desk
SevereFDA (Devices)·Z-0264-2023·Announced 2022-11-30

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
  • skin-injury
  • adhesive-malfunction

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.

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