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Recall Observatory FDA recall evidence

Device product

3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape

Z-0251-2023

October 06, 2022

Class II

Product summary

Firm
3M Healthcare Business
Event
Event 90989
Status
Ongoing
Classification
Class II
Quantity
807,720 units
Official record key
device-enforcement:Z-0251-2023

Official wording

Reason: During a recent investigation, 3M confirmed 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.

Code information: UDI/DI (01)50707387023756, Lot numbers: 33HR7D, 33HR94, 33HRET, 33HRWK, 33HT5X, 33HTDY, 33J4XP, 33J583, 33J5FA, 33JEF8, 33JEM5, 33JEYA, 33JWHK, 33JWLX, 33JWRH, 33JX5M, 33JXFA, 33JXPK, 33JY6E, 33JYEM, 33JYM4, 33JYXH, 33KD6N, 33KKET, 33KKMT, 33KL65, 33KLAR, 33L34N, 33L3JN, 33L3LT, 33L44T, 33LLC5

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During a recent investigation, 3M confirmed 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.