ACS IR - Angio Pack recallZ-1038-2022 · American Contract Systems, Inc. · initiated Mar 22, 2022
Open, Classified
Is my device affected?
- 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.
- 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.
- 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 was sterilized with a higher than specification EO concentration.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1038-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 22, 2022
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 24 packs
- Product code
- OIP
- Distribution
- US Nationwide distribution in the states of IL, MO, NE, and TX.
Product description
ACS IR - Angio Pack
Code information (models, lots, serial numbers)
Model JEIR37H, Lot 657211 UDI: 00191072151612
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ACS JEIR37HAmerican Contract Systems, Inc. · Angiography/angioplasty kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 89868).
- Z-1036-2022 · Open, Classified1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
- Z-1037-2022 · Open, Classified1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
- Z-1039-2022 · Open, ClassifiedACS Lap Chole Pack
- Z-1040-2022 · Open, ClassifiedACS Cath Lab Pack
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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