IR Procedure Pack, CEAT19W; Medical convenience kit

FDA device recall Z-3235-2024 · 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

OEQ

Quantity affected

1 unit

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