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Steri-Drape recallZ-0255-2023 · 3M Healthcare Business · initiated Oct 6, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from 3M Healthcare Business or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Component change control

What the company is doing

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 [email protected]. 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 [email protected]." 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 [email protected]. 4. To request credit, contact 3M Health Care Customer Helpline at 1-800-228-3957, option 7 or by email t

Recall details

Recall number
Z-0255-2023
Status
Open, Classified
Initiated by the company
Oct 6, 2022
Posted by the FDA
Nov 18, 2022
Recalling firm
3M Healthcare Business
Quantity
36,020 units
Product code
PUI
Distribution
Worldwide distribution.

Product description

3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape

Code information (models, lots, serial numbers)

UDI/DI (01)30707387058204, Lot numbers: 33H9HW, 33HXMD, 33JKD4, 33JKLL, 33KPXJ

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 90989).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page