Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
Summary
The FDA issued a Class II for Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; by Wilson-Cook Medical Inc.. Reason: There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue.
Details
Source
Device Recall
External ID
Z-1979-2023
Action Date
2023-06-28
Status
Ongoing
Category
device
Product Description
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
Lot/Code Info: UDI/DI : a) 00827002210493, b) 00827002213463; All unexpired lot numbers
Quantity Affected: 14,877 units
Reason for Recall
There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.
Distribution
US Nationwide - Worldwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-22
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 246 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-1979-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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