American Contract Systems, Inc. Recall: Pacemaker, COPM11B; Medical convenience kit
American Contract Systems, Inc. Recall: Pacemaker, COPM11B; Medical convenience kit is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: American Contract Systems, Inc.; Product: Pacemaker, COPM11B; Medical convenience kit; Reason for recall: ACS identified that due to an inoperable chart r
| Recalling firm | American Contract Systems, Inc. |
|---|---|
| Product | Pacemaker, COPM11B; Medical convenience kit |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US Nationwide distribution in the states of MO, MN, MA, OH, NE. |
| Recall initiated | 20240807 |
| Recall number | Z-3244-2024 |
| Category | device |
| State | MO |
| Country | United States |
$29/mo
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