FDA Device recall Z-3226-2024
PACEMAKER PACK, SLCV01J
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of PACEMAKER PACK, SLCV01J by American Contract Systems, citing 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 conf….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3226-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-07 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | American Contract Systems |
| Distribution | US |
Product
PACEMAKER PACK, SLCV01J; Medical convenience kit
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.
Identifiers
| code_info | UDI-DI: 00191072213846; Lot: 2405112; Exp: 05/11/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3226-2024%22
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