American Contract Systems Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
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
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; UDCO10F UDI-DI 191072216236 Lot 7987811 Bag serial number N/A * If bag serial number is listed as "N/A", then whole lot is affected
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →