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FDA Medical Device Recalls (openFDA)

HF Acquisition Co. LLC: STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.

Recall number
Z-2779-2020
Recalling firm
HF Acquisition Co. LLC
Product
STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.
Status
Terminated
Initiated
2020-06-05
Posted
not on file
Terminated
2022-02-01
Reason
A missing component (hand suction pump) in the emergency medical kits.
Root cause
Process change control
Action
On June 5, 2020, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification to customers via UPS Priority Overnight, informing them that their emergency medical kits were supplied without one of the intended medical devices inside. The notification informed the customers that the Recalling Firm is supplying the missing item and for them to place it inside their emergency medical kits. For any questions or information contact the Recalling Firm at 1-800-331-1984.
Quantity
2 kits
Distribution
US Nationwide distribution including in the states of TN and UT.
Lot, serial or model codes
STAT KIT Z-1000 Emergency Medical Kit Part Number: 1003550  AMBU Res-Cue Pump part number: 1004330
510(k) numbers
not on file
PMA numbers
not on file
Product code
LRR
Firm FEI
3014534
Firm city
Mukilteo
Firm state
WA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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