CLASS II Device recall · Reported 28 Jun 2017 · FDA Enforcement Report

QuikClot TraumaPad, sterile, soft, white recalled by Z-Medica

Z-Medica is recalling QuikClot TraumaPad, sterile, soft, white, X-ray detectable hemostatic dressing, distributed nationwide in the US. The recall was initiated on 17 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 7313

Quantity recalled2910 pieces

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2612-2017
FDA event ID: 77316
Recalling firm: Z-Medica, Wallingford, CT
Classification: Class II
Status: Terminated
Recall initiated: 17 May 2017
FDA classified: 19 Jun 2017
Reported: 28 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

17 May 2017	Recall initiated by company
19 Jun 2017	Classified by FDA	+33 days
28 Jun 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Packaging breach may compromise sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries

Where it was distributed

Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand

Nationwide

Questions about this recall

Why was it recalled?

Packaging breach may compromise sterility

Which lots are affected?

Lot # 7313

Where was it sold?

Worldwide Distribution - US (Nationwide) Foreign: South Korea, Taiwan, Thailand

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Z-Medica

All 3

Reported	Class	Recall	Company	Reason	Where
17 Nov 2021Device	CLASS II	QuikClot Combat Gauze-For Temporary External Use To Control recalled	Z-Medica	Sterility	Nationwide
14 Mar 2018Device	CLASS II	QuikClot TraumaPad, Part# 460 a topical dressing recalled by Z-Medica	Z-Medica	Other	Nationwide

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