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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79407

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 17, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Z-Medica, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0925-2018
Recall number
Z-0925-2018
Initiated
November 17, 2017
Classification
Class II
Status
Terminated
Recalling firm
Z-Medica, LLC
Quantity
4890

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

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Inspect official wording and provenance

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).

Code information

Part# 460, Lot# 7397

Distribution pattern

Nationally

Field note

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