Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Summary
The FDA issued a Class II for Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, steril by Wilson-Cook Medical Inc.. Reason: Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the acti.
Details
Source
Device Recall
External ID
Z-0582-2025
Action Date
2024-12-11
Status
Ongoing
Category
device
Product Description
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Lot/Code Info: UDI-DI 00827002246638, Lot numbers W4844245, exp. 6/10/2027; W4847501, exp. 6/20/2027; and W4851589, exp. 7/8/2027.
Quantity Affected: 46 devices
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-31
Company
Winston Salem, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Wilson-Cook Medical Inc. has 19 FDA actions in our database, including 16 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Wilson-Cook Medical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wilson-Cook Medical Inc. have FDA actions?
Wilson-Cook Medical Inc. has 19 FDA actions in our database, including 16 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0582-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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