CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report

QuikClot TraumaPad, Part# 460 a topical dressing recalled by Z-Medica

Z-Medica is recalling QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds, distributed nationwide in the US. The recall was initiated on 17 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart# 460, Lot# 7397

Quantity recalled4890

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-0925-2018
FDA event ID: 79407
Recalling firm: Z-Medica, Wallingford, CT
Classification: Class II
Status: Terminated
Recall initiated: 17 Nov 2017
FDA classified: 8 Mar 2018
Reported: 14 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

17 Nov 2017	Recall initiated by company
8 Mar 2018	Classified by FDA	+111 days
14 Mar 2018	Published in enforcement report	+6 days

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

Reason for recall

A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot TraumaPad" pouch. The carton as well as the remaining 9 pouches were properly identified as QuikClot Trauma Pad. The customer alleged that when the pouch was opened, it contained a QuikClot TraumaPad. All 10 pouches in the box had the correct part number, lot number, and expiration date for the prod uct (QuikClot TraumaPad).

Product as listed by the FDA

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 traumatic injuries

Where it was distributed

Nationally

Nationwide

Questions about this recall

Is QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds recalled?

Yes. Z-Medica recalled QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds on 17 Nov 2017. The recall is Class II and its status is Terminated. Recall number Z-0925-2018.

Why was it recalled?

Which lots are affected?

Part# 460, Lot# 7397

Where was it sold?

Nationally

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 21 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
28 Jun 2017Device	CLASS II	QuikClot TraumaPad, sterile, soft, white recalled by Z-Medica	Z-Medica	Sterility	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide