American Contract Systems Inc recalls AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K

Recalled July 17, 2024 · FDA recall Z-2274-2024 · American Contract Systems

Hazard

Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. · FDA Class II

Units

345 units

Sold at

US Nationwide distribution.

Description

Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.

Product

AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K

Manufacturer(s)

American Contract Systems Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →