The Recall Desk
SevereFDA (Devices)·Z-0248-2023·Announced 2022-11-30

3M Steri-Drape surgical drapes recalled due to adhesive defect and skin injuries

3M is recalling 504,000 units of Steri-Drape surgical drapes worldwide because the adhesive liner is difficult to remove and may damage the product. Reported cases of adhesive-related skin injuries have been associated with the affected lots.

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: This FDA Class II medical device recall involves reported adhesive-related skin injuries, meeting the rubric criterion for Severe (Score 4): 'significant injury/property-damage reports.' Reported patient injuries constitute significant injury reports, justifying the Severe classification.

Plain-English summary

3M Healthcare Business is recalling 3M Steri-Drape Small Towel Drape (REF 1000NS), a general surgery drape. A total of 504,000 units are affected. The recalled product can be identified by these specific lot numbers: 33HP4H, 33HPDN, 33HPLM, 33HPWP, 33J478, 33J8MT, 33J948, 33JLMY, 33JLWL, 33K6FN, 33KCDK, 33KCP4, 33KY37, 33KYDK, and 33KYNY.

The recall was initiated after 3M confirmed that the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive-related skin injuries for these affected lots.

This product has been distributed worldwide. Healthcare facilities that have received affected lots should immediately discontinue use and contact 3M for return or replacement information.

Any patients or healthcare workers who have experienced adverse events with this product should report the incident to the FDA or contact 3M directly.

The recalled product

Product
3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
Manufacturer
3M Healthcare Business
Category
Medical Device — Surgical Supplies
Hazard
  • adhesive-skin-injury
  • product-defect

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 (16)

  • UDI/DI (01)50707387023381
  • Lot Numbers: 33HP4H
  • 33HPDN
  • 33HPLM
  • 33HPWP
  • 33J478
  • 33J8MT
  • 33J948
  • 33JLMY
  • 33JLWL
  • 33K6FN
  • 33KCDK
  • 33KCP4
  • 33KY37
  • 33KYDK
  • 33KYNY

Distribution

Distribution scope not specified by the agency.

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