1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
Check against the official notice below — it lists the full affected range.
American Contract Systems, Inc. is recalling three surgical instrument kits that were sterilized using ethylene oxide (EO) at concentrations higher than the manufacturer's specifications. The recall affects 114 packs distributed nationwide in Illinois, Missouri, Nebraska, and Texas, including the ACS Arthroscopy Kit (Model LMAR15R, Lot 981221), the ACS Knee Kit (Model LWKN46N, Lot 966221), and the ACS Hand Pack (Model FHHP63T, Lot 966221).
The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Product was sterilized with a higher than specification EO concentration.
Reason for recall: Product was sterilized with a higher than specification EO concentration. Distribution: US Nationwide distribution in the states of IL, MO, NE, and TX. Quantity: 114 packs Lot/code info: 1) ACS Arthroscopy Kit - Model LMAR15R, Lot 981221; UDI: 00191072152978 2) ACS Knee Kit - Model LWKN46N, Lot 966221; UDI: 00191072150158 3) ACS Hand Pack - Model FHHP63T, Lot 966221, UDI: 00191072149954
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.