QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Summary
The FDA issued a Class II for QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding by Z-Medica, LLC. Reason: Lack of Packaging seal integrity may result in a sterile barrier breach..
Details
Source
Device Recall
External ID
Z-0211-2022
Action Date
2021-11-17
Status
Terminated
Category
device
Product Description
QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
Lot/Code Info: Lot# 12645 UDI I Primary DI Number: 00841495102004
Quantity Affected: 2400 units
Reason for Recall
Lack of Packaging seal integrity may result in a sterile barrier breach.
Distribution
US Nationwide distribution in the state of NC.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-22
Company
Wallingford, CT
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 102 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Z-Medica, LLC has 2 FDA actions in our database, including 1 recall and 1 clearance.
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 (Z-Medica, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Z-Medica, LLC have FDA actions?
Z-Medica, LLC has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0211-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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