FDA recall Z-0484-2024

Atrium Medical Corporation · Class II · device

Product

Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

Reason for recall

A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.

Distribution

US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX

Key facts

Status
Ongoing
Initiation date
2023-09-29
Report date
2023-12-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Merrimack, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0484-2024