Recall Z-0582-2025— Wilson-Cook Medical Inc.
Class II · Ongoing
Class II FDA medical device recall by Wilson-Cook Medical Inc., initiated 2024-10-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.. Reason: 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..
- Recalling firm
- Wilson-Cook Medical Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-31
- Firm location
- Winston Salem, NC, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.