Reported Oct 22, 2025 · Ongoing
Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO…
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 HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 191072232168ANCA80AP UDI-DI 191072232168 Lot 8077111 Bag serial number 68119740 2 191072232267HSAN63N UDI-DI 191072232267 Lot 8097211 Bag serial number N/A 3 191072201928IHAN02W UDI-DI 191072201928 Lot 7961811 Bag serial number 68086881 Lot 8037411 Bag serial number N/A 4 191072216014MHCA98AK UDI-DI 191072216014 Lot 8006711 Bag serial number 47415134 Lot 8133011 Bag serial number N/A 5 191072229632RCAN45C UDI-DI 191072229632 Lot 8537111 Bag serial number 68872542 6 191072216236UDCO10F UDI-DI 191072216236 Lot 7987811 Bag serial number N/A * If bag serial number is listed as "N/A", then whole 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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