American Contract Systems, Inc.: Medical Device Recall in 2024 - (Recall #: Z-3226-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

PACEMAKER PACK, SLCV01J; Medical convenience kit

Product Classification:

Class II

Date Initiated: August 7, 2024

Date Posted: October 2, 2024

Recall Number: Z-3226-2024

Event ID: 95261

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.

Status: Ongoing

Product Quantity: 20 units

Code Information:

UDI-DI: 00191072213846; Lot: 2405112; Exp: 05/11/2025

Distribution Pattern:

US Nationwide distribution in the states of MO, MN, MA, OH, NE.

Voluntary or Mandated:

Voluntary: Firm initiated