Facility

Z-MEDICA, LLC

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

Key facts

3recalls · worst Class II

1inspections · worst VAI

—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)	3015437221
Establishment type	Repack or Relabel Medical Device
Location	222 Universal Drive North Haven, CT, US 06473
Registration status	Active · expires 2026
Parent company	Z-MEDICA, LLC (owner-operator 9048106)
Brand names	QuikClot Interventional

Activity by year

Recalls (3)
Inspections (1)

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 (1)

NAI2019-10-01
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 3015437221) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015437221-z-medica-llc/

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