Z-Medica Recalls QuikClot TraumaPad Dressings Due to Labeling Error
Z-Medica is recalling 4,890 units of QuikClot TraumaPad dressings because one pouch in a box was mislabeled as a different product, though the contents were correct.
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: This is a minor labeling error where the product contents were correct, fitting the rubric criteria for moderate severity involving minor labeling issues.
Plain-English summary
Z-Medica, LLC is recalling 4,890 units of QuikClot TraumaPad, Part# 460, a topical dressing used for the local management of bleeding wounds. The recall was initiated after a customer reported that one pouch in a box of 10 was labeled "QuikClot Roll" instead of "QuikClot TraumaPad." The customer alleged that the pouch contained the correct QuikClot TraumaPad product, and the remaining nine pouches in the box were properly identified.
The affected product is identified by Part# 460 and Lot# 7397. All 10 pouches in the affected box had the correct part number, lot number, and expiration date for the QuikClot TraumaPad. The product was distributed nationally.
Consumers who have this product should stop using it and contact Z-Medica, LLC for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and…
- Manufacturer
- Z-Medica, LLC
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 4,890
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 (2)
- Part# 460
- Lot# 7397
Distribution
Distribution scope not specified by the agency.
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