Cook Medical HEMO-7-EU Hemospray Devices Recalled for Activation Knob Defect
Cook Medical HEMO-7-EU Hemospray devices are being recalled because the activation knob may crack or break during use due to manufacturing defects. The affected devices were distributed to Argentina, Brazil, and Israel.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a manufacturing defect that may cause the activation knob to crack or break during device use. While the defect creates a risk of device malfunction during endoscopic hemostasis procedures, the recall notice does not report any illnesses or injuries.
Plain-English summary
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat devices (reference G24663, 2.8 cm) are subject to a recall by Wilson-Cook Medical Inc. due to a manufacturing defect affecting 46 devices.
Specific lots were manufactured with nonconforming raw materials that can cause the red activation knob to crack or break at the internal threading when the device is activated. This defect may compromise the device's ability to function properly during endoscopic procedures.
The recalled devices were distributed outside the United States to Argentina, Brazil, and Israel. The affected lot numbers are W4844245 (expiration 6/10/2027), W4847501 (expiration 6/20/2027), and W4851589 (expiration 7/8/2027).
The recalled product
- Product
- Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
- Manufacturer
- Wilson-Cook Medical Inc.
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI-DI 00827002246638
- Lot numbers W4844245
- exp. 6/10/2027
- W4847501
- exp. 6/20/2027
- and W4851589
- exp. 7/8/2027.
Distribution
Distribution scope not specified by the agency.
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