Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat recall
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Why was Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00827002246638, Lot numbers W4844245, exp. 6/10/2027; W4847501, exp. 6/20/2027; and W4851589, exp. 7/8/2027.
- Product
- Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
- Recalling firm
- Wilson-Cook Medical Inc.
- Quantity
- 46 devices
- Distribution
- Distribution was OUS only to Argentina, Brazil, and Israel.
- Recall date
- December 11, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)