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General Pack, REF BBGP31C recallZ-0171-2024 · American Contract Systems, Inc. · initiated Sep 1, 2023

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 American Contract Systems, Inc. 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 an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.

FDA root cause category: Process control

What the company is doing

Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 09/01/2023 by email. The notice explained the issue, risk, and requested the user discontinue the use of the I.V. Cath and Adhesive Dermabond and affix a warning label to each kit and case of affected product in inventory. The firm sent an updated letter on 09/22/2023 via email which corrected the product distribution date.

Recall details

Recall number
Z-0171-2024
Status
Open, Classified
Initiated by the company
Sep 1, 2023
Posted by the FDA
Oct 26, 2023
Recalling firm
American Contract Systems, Inc.
Quantity
57 cases
Product code
LRO
Distribution
US Nationwide distribution in the states of FL, IA.

Product description

General Pack, REF BBGP31C

Code information (models, lots, serial numbers)

UDI/DI 00191072166609, Lot Number 968231

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 93086).

Sources and updates

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