HIGH

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

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.

Quick Facts at a Glance

Recall Date
September 4, 2025
Hazard Level
HIGH
Brand
American Contract Systems
Geographic Scope
1 states

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter

Full Description

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. Reason: 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.. Classification: Class II. Quantity: 32,433 total. Distribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
ANCA80AP UDI-DI 191072232168 Lot 8077111 Bag serial number 68119740
HSAN63N UDI-DI 191072232267 Lot 8097211 Bag serial number N/A
IHAN02W UDI-DI 191072201928 Lot 7961811 Bag serial number 68086881 Lot 8037411 Bag serial number N/A
MHCA98AK UDI-DI 191072216014 Lot 8006711 Bag serial number 47415134 Lot 8133011 Bag serial number N/A
RCAN45C UDI-DI 191072229632 Lot 8537111 Bag serial number 68872542
+2 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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