FDA recall Z-1240-2022

Cook Incorporated · Class II · device

Product

Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)

Reason for recall

The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

Key facts

Status
Ongoing
Initiation date
2022-05-05
Report date
2022-06-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1240-2022