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U.S. Department of Health and Human Services

Class 2 Device Recall 3M SteriDrape

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  Class 2 Device Recall 3M SteriDrape see related information
Date Initiated by Firm October 06, 2022
Date Posted November 18, 2022
Recall Status1 Open3, Classified
Recall Number Z-0253-2023
Recall Event ID 90989
Product Classification Drape, surgical, exempt - Product Code PUI
Product 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape
Code Information UDI/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
Recalling Firm/
Manufacturer		 3M Healthcare Business
2510 Conway Ave E
Saint Paul MN 55144-4147
For Additional Information Contact 3M Health Care Helpline
800-228-3957 Ext. 7
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Component change control
Action The firm began disseminating an URGENT Product Recall notice their consignees by email or letter beginning 10/06/2022. The notice explained the issue and requested the following: Distributors: "Actions Requested: 1. Immediately discontinue distribution of affected models and lots of 3M" Steri-Drape" Surgical Drapes. Reference Attachment 1 for list of models and lots. 2. Determine if any stock of the affected models and lots remain in inventory. 3. Complete the Distributor Acknowledgement Form with the following: " Acknowledge that you have read and understood this letter whether or not you have any 3M" Steri-Drape" Surgical Drapes in stock at your facility; and " Indicate if you have any product in stock and dispose of this material per facility policy. " Email the completed form to 3MFieldSafetyAction@montage72.com. 4. Notify any of your customers who have purchased this product using the Customer Letter and Customer Acknowledgement Form provided. 5. To request credit, contact 3M Health Care Customer Helpline at 1-800-228-3957, option 7 or by email to 3MFieldSafetyAction@montage72.com." Direct accounts: "Actions Requested: 1. Immediately cease use of affected models and lots of 3M" Steri-Drape" Surgical Drapes. Reference Attachment 1 for list of models and lots. 2. Determine if any stock of the affected models and lots remain in inventory. NOTE: if you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 3. Complete the Customer Acknowledgement Form with the following: " Acknowledge that you have read and understood this letter whether or not you have any 3M" Steri-Drape" Surgical Drapes in stock at your facility; and " Indicate if you have any product in stock and dispose of this material per facility policy. " Email the completed form to 3MFieldSafetyAction@montage72.com. 4. To request credit, contact 3M Health Care Customer Helpline at 1-800-228-3957, option 7 or by email t
Quantity in Commerce 769,810 units
Distribution Worldwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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