Facility

Z-MEDICA, LLC

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004138549
Establishment type	Manufacture Medical Device
Location	4 FAIRFIELD BLVD. Wallingford, CT, US 06492
Registration status	Active · expires 2026
Parent company	Z-MEDICA, LLC (owner-operator 9048106)
Brand names	QuikClot Combat Gauze, QuikClot EMS, QuikClot Combat Gauze TraumaPad, QuikClot Bleeding Control Dressing

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (1)

Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Product code QSY (opens in a new tab) · Unclassified · Unknown

Recalls & enforcement

Class IITerminated2021-09-22
Lack of Packaging seal integrity may result in a sterile barrier breach.
Class IITerminated2017-11-17
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 con…
Class IITerminated2017-05-17
Packaging breach may compromise sterility

FDA inspections (2)

NAI2023-03-10
No Action Indicated · Bioresearch Monitoring
NAI2018-05-10
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Z-MEDICA, LLC (FEI 3004138549) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004138549-z-medica-llc/

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