—#209848

Product

Cath Lab Pack, CECL02P; Medical convenience kit

FDA product code: OES — Cardiac Catheterization Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: UDI-DI: 00191072206497; Lot: 2405102; Exp: 05/10/2025

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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."

Recalling firm

Firm: American Contract Systems, Inc.
Address: 2610 Ne Industrial Dr, Ste 220, Kansas City, Missouri 64117-2648

Distribution

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

Timeline

Recall initiated: 2024-08-07
Posted by FDA: 2024-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209848. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.