Pacemaker COPM11B Medical Kits Recalled for Sterilization Verification Issue
American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.
- Product
- Pacemaker, COPM11B; Medical convenience kit
- Category
- Medical Device
- Distribution
- Distributed nationwide