CUSTOM KNEE Medical Device Procedure Kit recalled for excess chemical residuals
American Contract Systems Inc is recalling 174 units of the CUSTOM KNEE - 206061-Procedure Kit due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component. The residuals exceed the safety limits specified in ANSI/AAMI/ISO 10993-7:(R)2012 for permanent-contact medical devices.
- Product
- CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE
- Category
- Medical Device
- Distribution
- Distributed nationwide