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3M Healthcare Business Recall 90989

Description: 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape

3M Healthcare Business Recall 90989 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0253-2023
Event ID90989
Event Description3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape
Product TypeDevices
DistributionWorldwide distribution.
Quantity769,810 units
Recall ReasonDuring 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.
Device Classification20221130
Device Code InfoUDI/DI (01)30707387018772, Lot numbers: 33H9T5, 33HA9D, 33HC7R, 33HCJN, 33HCPL, 33HD6C, 33HDYW, 33HEDM, 33HELH, 33HF3X, 33HFXP, 33HH8C, 33HHKC, 33HJ3K, 33HK5H, 33HKJH, 33HKPA, 33HLKE, 33HLWT, 33HNJ3, 33HNXX, 33HY4Y, 33HYCP, 33J3LW, 33J43T, 33J4E7, 33J4M7, 33J5CP, 33J798, 33J7KC, 33J7YJ, 33J8A7, 33J97T, 33J9JR, 33J9RC, 33JA5D, 33JAED, 33JC7L, 33JCHH, 33JCPY, 33JD5A, 33JE49, 33JEEM, 33JEP8, 33JFAJ, 33JFJX, 33JPDM, 33JPPC, 33JR3D, 33JRCR, 33JRNA, 33JTFX, 33JTNY, 33JW4L, 33JWD4, 33JWLR, 33JXEM, 33JXRJ, 33JY7J, 33JYFL, 33JYMH, 33K3AE, 33K3N7, 33K6CJ, 33K7CL, 33K7NF, 33K9A3, 33K9JW, 33K9R5, 33K9YW, 33KAXL, 33KC8P, 33KCJT, 33KCX3, 33KE37, 33KHXA, 33KJAA, 33KJL5, 33KJWK, 33KKMY, 33KL5W, 33KLMN, 33KM4C, 33KN54, 33KNAX, 33KR5C, 33KRDE, 33KRR5, 33KTNC, 33KW4K, 33KWEX, 33KWT5, 33KXRH, 33KYA3, 33KYKA, 33KYWT, 33L3YR, 33L6EW, 33L6M5, 33L7RH
Center Classification Date20221118
Recall Initiation Date20221006
Recalling Firm3M Healthcare Business
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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