Z-2523-2024Class II

American Contract Systems Biopsy Drape Pack convenience kit

Name: Z-2523-2024 American Contract Systems Biopsy Drape Pack convenience kit
Creator: American Contract Systems, Inc.
Published: 2024-05-06
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2024-05-06 / Open, Classified / root cause: sterility

FDA source

American Contract Systems, Inc. began a recall of American Contract Systems Biopsy Drape Pack convenience kit on 2024-05-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2523-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-06
Posted: 2024-08-07
Recalling firm: American Contract Systems, Inc.
Product: American Contract Systems Biopsy Drape Pack convenience kit
Product code: FCH Tray, Biopsy, Without Biopsy Instruments
Reason for recall: 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
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 224
Distribution: US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
Product codes and lots: UDI-DI 00191072202246; Lot 981241; Exp. Date 1/19/2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2523-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2517-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-07
Z-2518-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-07
Z-2519-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-07
Z-2520-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-07
Z-2521-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-07
Z-2522-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-07
Z-2523-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-07
Z-2524-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-07

Product code FCH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)