FDAClass IIJune 28, 2017

QuikClot TraumaPad recall: Sterility Concern

QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard…

Why was QuikClot TraumaPad recalled?

Packaging breach may compromise sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 7313

Product
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard…
Recalling firm
Z-Medica, LLC
Quantity
2910 pieces
Distribution
Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand
Recall date
June 28, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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