PACEMAKER PACK, SLCV01J; Medical convenience kit

FDA device recall Z-3226-2024 · posted 2024-09-24 · Open, Classified

Recall details

Recalling firm

American Contract Systems, Inc.

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.

Action taken

Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " -Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Discard all affected kits and document on the enclosed Response Form."

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OEZ

Quantity affected

20 units

Distribution

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

Date initiated

2024-08-07

Date posted

2024-09-24

Location

Kansas City, MO