Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3226-2024 — PACEMAKER PACK, SLCV01J; Medical convenience kit

U.S. FDA — Device Enforcement · United States · 2024-08-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3226-2024
Date of alert
2024-08-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
American Contract Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00191072213846
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.