American Contract Systems, Inc.: PACEMAKER PACK, SLCV01J; Medical convenience kit

Hazard

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.

Details from the source

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. Distribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE. Quantity: 20 units Lot/code info: UDI-DI: 00191072213846; Lot: 2405112; Exp: 05/11/2025

UPC codes

00191072213846

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.