FDA recall Z-0582-2025

Product

Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.

Reason for recall

Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.

Distribution

Distribution was OUS only to Argentina, Brazil, and Israel.

Key facts

Status

Ongoing

Initiation date

2024-10-31

Report date

2024-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Winston Salem, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0582-2025