FDAFDA · Food and drugs·Recall number Z-0250-2023
3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape
Published November 30, 2022 · Recall initiated: October 6, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- 3M Healthcare Business
- Distributor
- Worldwide distribution.
- Lot
- UDI/DI (01)30707387057252, Lot numbers: 33HAET, 33HAPR, 33HAYX, 33HC8R, 33HCEX, 33HH47, 33HHC9, 33HHKA, 33HHTA, 33HJA9, 33HJH7, 33HJNT, 33HK4K, 33HKD8, 33HKHT, 33HKPP, 33HKRT, 33HL59, 33HL9X, 33HLLW, 33HLXD, 33HMAD, 33HMJH, 33HMWA, 33HN5C, 33HND4, 33HNWM, 33HYNH, 33HYTN, 33J33L, 33J37F, 33J3EL, 33J3NC, 33J44N, 33J9CP, 33J9FN, 33J9TH, 33JA7C, 33JADN, 33JAMH, 33JATF, 33JC94, 33JCK8, 33JCMJ, 33JD45, 33JDF6, 33JDPK, 33JDT4, 33JFDY, 33JFHJ, 33JHAC, 33JHJ4, 33JJ4H, 33JJ9P, 33JJF7, 33JJT9, 33JM5W, 33JMDH, 33JMKP, 33JMTJ, 33JN8N, 33JNNF, 33JPHR, 33JPKT, 33JPWT, 33KDER, 33KDMN, 33KDY5, 33KE9E, 33KEL3, 33KF3N, 33KF83, 33KFRC, 33KFY9, 33KH7R, 33KHCM, 33KHLJ, 33KHX3, 33KJ63, 33KJEX, 33KJNK, 33KK5D, 33KKC4, 33KLHM, 33KLNH, 33KLWJ, 33KM9K, 33KMJH, 33KMLN, 33KN3J, 33KNAJ, 33KNN4, 33KNXW, 33KP63, 33KPJY, 33KPYP, 33KRC5, 33KRPW, 33KT57, 33KT9N, 33KTEM, 33L4D6, 33L4K4, 33L4X5, 33L5C7, 33L5P5, 33L5X3, 33L64A, 33L6D7, 33L6N4, 33L6XH, 33L7AM, 33L7FX, 33L7XL, 33L878, 33LDF8, 33LDPJ, 33LED4, 33LETX, 33LF49, 33LFJ9, 33LFPM, 33LH6E
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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