FDA recall Z-1362-2022

Cook Incorporated · Class II · device

Product

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

Reason for recall

The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.

Distribution

US Nationwide. Brazil, Canada,

Key facts

Status
Completed
Initiation date
2022-05-25
Report date
2022-07-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1362-2022