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American Contract Systems Biopsy Drape Pack convenience kit recallZ-2523-2024 · American Contract Systems, Inc. · initiated May 6, 2024

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

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

FDA root cause category: Under Investigation by firm

What the company is doing

The recalling firm issued recall letters on and dated 5/6/2024 via email or overnight mail. The letter explained the event details, product involved, risk to health, and actions to take. The actions included (1) review your inventory and segregate and quarantine all affected trays. If any of the trays have been further distributed, ensure all end users are notified and maintain records of effectiveness; (2) discard all affected kits and document on the enclosed Response Form; and (3) complete the enclosed Response Form and return it as soon as possible.

Recall details

Recall number
Z-2523-2024
Status
Open, Classified
Initiated by the company
May 6, 2024
Posted by the FDA
Aug 7, 2024
Recalling firm
American Contract Systems, Inc.
Quantity
224
Product code
FCH
Distribution
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.

Product description

American Contract Systems Biopsy Drape Pack convenience kit

Code information (models, lots, serial numbers)

UDI-DI 00191072202246; Lot 981241; Exp. Date 1/19/2025

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 94908).

Sources and updates

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