American Contract Systems, Inc. Recall 95261
Description: Pacemaker, COPM11B; Medical convenience kit
American Contract Systems, Inc. Recall 95261 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-3244-2024 |
Event ID | 95261 |
Event Description | Pacemaker, COPM11B; Medical convenience kit |
Product Type | Devices |
Distribution | US Nationwide distribution in the states of MO, MN, MA, OH, NE. |
Quantity | 3 units |
Recall Reason | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
Device Classification | 20241002 |
Device Code Info | UDI-DI: 00191072206312; Lot: 2405033; Exp: 05/03/2025 |
Center Classification Date | 20240924 |
Recall Initiation Date | 20240807 |
Recalling Firm | American Contract Systems, Inc. |
Initial Notification | |
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