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Medical convenience kits recallZ-0175-2026 · American Contract Systems Inc. · initiated Sep 4, 2025

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

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.

Recall details

Recall number
Z-0175-2026
Status
Open, Classified
Initiated by the company
Sep 4, 2025
Posted by the FDA
Oct 16, 2025
Recalling firm
American Contract Systems Inc.
Quantity
32,433 total
Product code
OES
Distribution
US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Product description

Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

AMCL05P UDI-DI 191072207296 Lot 7990011 Bag serial no. N/A Lot 8170111 Bag serial numbers 68194152 68194153 68194160 68194176 68194179 68194182 68194190 Lot 8526511 Bag serial numbers 68873157 68874410; EVLH67F UDI-DI 191072232380 Lot 8211011 Bag serial number N/A Lot 8367311 Bag serial number 68570438; FDCL22R UDI-DI 191072185259 Lot 8048511 Bag serial numbers 68045373 68045376; IHCC03X UDI-DI 191072226273 Lot 80111 Bag serial number N/A Lot 8085711 Bag serial numbers 47506640 47506761; TNCC02AD UDI-DI 191072212757 Lot 7970911 Bag serial number N/A Lot 8045911 Bag serial number 47503192 Lot 8426711 Bag serial number 47886615; UICC27AG UDI-DI 191072231307 Lot 8085511 Bag serial number N/A Lot 8167611 Bag serial number 68194108; UIRD89AH UDI-DI 191072231314 Lot 8068111 Bag serial number 47499672 47499908 * if Bag serial number is "n/a", then all of that lot is affected

Devices named in this recall

7 devices 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 97659).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page