Reported Oct 22, 2025 · Ongoing
Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH…
American Contract Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems Inc. · 1601 Se Gateway Dr Ste 120 · Grimes, IA · 50111-5223
Is this the product you have?
- 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)
- Lot codes and dates
7 of 7 products
Products covered by this recall # Barcodes Product as published 1 191072207296AMCL05P 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 2 191072232380EVLH67F UDI-DI 191072232380 Lot 8211011 Bag serial number N/A Lot 8367311 Bag serial number 68570438 3 191072185259FDCL22R UDI-DI 191072185259 Lot 8048511 Bag serial numbers 68045373 68045376 4 191072226273IHCC03X UDI-DI 191072226273 Lot 80111 Bag serial number N/A Lot 8085711 Bag serial numbers 47506640 47506761 5 191072212757TNCC02AD UDI-DI 191072212757 Lot 7970911 Bag serial number N/A Lot 8045911 Bag serial number 47503192 Lot 8426711 Bag serial number 47886615 6 191072231307UICC27AG UDI-DI 191072231307 Lot 8085511 Bag serial number N/A Lot 8167611 Bag serial number 68194108 7 191072231314UIRD89AH UDI-DI 191072231314 Lot 8068111 Bag serial number 47499672 47499908 * if Bag serial number is "n/a", then all of that lot is affected - Amount recalled
- 32,433 total
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new American Contract Systems Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.