Z-1038-2022Class II

ACS IR - Angio Pack

Name: Z-1038-2022 ACS IR - Angio Pack
Creator: American Contract Systems, Inc.
Published: 2022-03-22
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2022-03-22 / Open, Classified / root cause: manufacturing process

FDA source

American Contract Systems, Inc. began a recall of ACS IR - Angio Pack on 2022-03-22. FDA classified it as Class II and gives the reason as "Product was sterilized with a higher than specification EO concentration". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1038-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-22
Posted: 2022-05-06
Recalling firm: American Contract Systems, Inc.
Product: ACS IR - Angio Pack
Product code: OIP Radiology-Diagnostic Kit
Reason for recall: Product was sterilized with a higher than specification EO concentration.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A customer letter dated 04/05/2022 was issued to impacted consignees. The letter instructs the following: 1) Review your inventory and segregate affected product. This product should not be shipped out to customers. 2) Return affected product to 2610 NE Industrial Drive, Suite 220, Kansas City, MO 64120. 3) If product was already further distributed, ensure that all downstream customers are properly notified of the recall and maintain records of effectiveness. A Field Action Response Form should be completed and returned to [email protected], even if you do not have product inventory.
Quantity in commerce: 24 packs
Distribution: US Nationwide distribution in the states of IL, MO, NE, and TX.
Product codes and lots: Model JEIR37H, Lot 657211 UDI: 00191072151612

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1038-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1036-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-06
Z-1037-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-06
Z-1038-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-06
Z-1039-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-06
Z-1040-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-06

Product code OIP

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)