Z-Medica Recalls QuikClot TraumaPad Due to Packaging Sterility Concerns
Z-Medica is recalling 2,910 units of QuikClot TraumaPad hemostatic dressings because packaging breaches may compromise sterility.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Z-Medica, LLC is recalling 2,910 units of QuikClot TraumaPad hemostatic dressings (Part Number 460, Lot # 7313). The recall is being conducted because a packaging breach may compromise the sterility of the medical device.
The affected products were distributed worldwide, including in the United States, South Korea, Taiwan, and Thailand. The QuikClot TraumaPad is a sterile, soft, white, X-ray detectable dressing used for the local management of bleeding wounds such as cuts, lacerations, and abrasions, as well as for the temporary treatment of severely bleeding wounds.
Consumers and healthcare providers should stop using the affected QuikClot TraumaPad dressings and contact Z-Medica, LLC for further instructions on how to return or dispose of the product.
The recalled product
- Product
- QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations…
- Manufacturer
- Z-Medica, LLC
- Hazard
- Affected units
- 2,910
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 (1)
- Lot # 7313
Distribution
Distributed nationwide across the United States.
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