FDA Device Recall Z-0004-2025: Mercury Enterprises, Inc. dba Mercury Medical

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0004-2025.

Recall Res Number

Z-0004-2025

Recalling Firm / Manufacturer

Mercury Enterprises, Inc. dba Mercury Medical

FEI Number

1024404

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-08-30

Date Posted

2024-10-02

Date Terminated

N/A

Product Code

BTL

Event Number

95303

Product Quantity

1,300 units

Product Description Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

Reason for Recall Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

Action Details Mercury Medical notified customers on 09/04/2024 via letter. Consignees who are medical facilities were instructed to immediately review inventory and quarantine any affected units on hand, contact customer service to arrange return of units, and complete the return response form. Consignees who are distributors were instructed to notify customers if further distributed, obtain a response form from those customers, arrange for any return of affected units, and complete the return response form.

Distribution Pattern US distribution to MI, FL, SC, PA, IN. International distribution to Albania.

Code Information / Serial Numbers Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.

Related Establishments / Registrations

MERCURY MEDICAL Registration: 1024404 View Registration
SunMed Group Holdings, LLC Registration: 1314417 View Registration
ICU Medical, Inc. Registration: 1526863 View Registration
INTERNATIONAL BIOMEDICAL, LTD. Registration: 1625392 View Registration
OXYGEN THERAPY INSTITUTE Registration: 1823393 View Registration
Allied Medical LLC Registration: 1924066 View Registration
Anesthesia Associates, Inc. Registration: 2022648 View Registration
FISHER & PAYKEL HEALTHCARE, INC. Registration: 2085602 View Registration
AXCESOR LLC Registration: 2134752 View Registration
INSTRUMENTATION INDUSTRIES, INCORPORATED Registration: 2518436 View Registration
VORTRAN MEDICAL TECHNOLOGY 1, INC. Registration: 2951529 View Registration
DRAEGERWERK AG & CO. KGAA Registration: 3001104093 View Registration
AIRON CORPORATION Registration: 3003697063 View Registration
ATOM MEDICAL CORPORATION Registration: 3005652389 View Registration
DRAEGER MEDICAL SYSTEMS, INC. Registration: 3005783425 View Registration
THORNHILL RESEARCH INC. Registration: 3005803793 View Registration
SUNMED AP, LTD. Registration: 3005998497 View Registration
GaleMed (Xiamen) Co., Ltd. Registration: 3006783791 View Registration
WIPRO GE HEALTHCARE PRIVATE Ltd. Registration: 3007734888 View Registration
SAFEGUARD US OPERATING, LLC Registration: 3008258694 View Registration
Dongguan Plastiflex Hose Technology Ltd Registration: 3008342612 View Registration
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. Registration: 3008729547 View Registration
Integra Biotechnical, SA de CV Registration: 3009746061 View Registration
SONOCO PLASTICS B.V. Registration: 3009884346 View Registration
ICU Medical Czech Republic a. s. Registration: 3011237704 View Registration
Katmai Health Services LLC Registration: 3012104670 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
ICU Medical Nederland B.V. Registration: 3012542015 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
Datex-Ohmeda, Inc. Registration: 3014220748 View Registration
KATMAI INTEGRATED SOLUTIONS Registration: 3015997711 View Registration
WEINMANN EMERGENCY MEDICAL TECHNOLOGY GMBH Registration: 3017365972 View Registration
BOUND TREE MEDICAL, LLC Registration: 3020460367 View Registration
LINAMAR INNOVATION HUB Registration: 3020476987 View Registration
MAGNAMED TECNOLOGIA MEDICA S/A Registration: 3024290085 View Registration
MDL SOLUTIONS INCORPORATED Registration: 3025434453 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
INTERNATIONAL EMERGENCY SERVICES S.L Registration: 3031754300 View Registration
Datex-Ohmeda, Inc. Registration: 3036470679 View Registration
SUNMED AP, LTD., WAREHOUSE NO. 2 Registration: 3044994756 View Registration
GALEMED CORP. Registration: 8043316 View Registration
PLAXTRON INDUSTRIAL (M) SDN. BHD. Registration: 8044169 View Registration
O-TWO MEDICAL TECHNOLOGIES, INC. Registration: 9610861 View Registration
FISHER & PAYKEL HEALTHCARE, LTD. Registration: 9611451 View Registration
Draegerwerk AG & Co. KGaA Registration: 9611500 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9616567 View Registration
CPR Medical Devices Inc. Registration: 9681209 View Registration

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Medical Device Recall: Z-0004-2025

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer