Mercury Enterprises, Inc. dba Mercury Medical: Device Recall

Recall #Z-0821-2025 · 12/10/2024

Class I: Dangerous

Recall Details

Recall Number
Z-0821-2025
Classification
Class I
Product Type
Device
Recalling Firm
Mercury Enterprises, Inc. dba Mercury Medical
Status
Ongoing
Date Initiated
12/10/2024
Location
Clearwater, FL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
37370

Reason for Recall

Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.

Product Description

Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842

Distribution Pattern

Worldwide Distribution: US (nationwide) to states of: PA, FL, IN, WI, ME, SC, WY, ID, MT, TX, MI, LA, MS, AR, WV, MD, KY, NJ, WA, CA, GA, MO, MA, NC, NV, TN, VA, OK, ND, MN, AL, HI, UT, NY, AZ, IL, OH, IA, NE, CT, AK, OR and OUS (foreign) to countries of: Hungary, Switzerland, Hong Kong, Spain, Canada, Italy, United Kingdom, United Arab Emirates, Saudi Arabia, France, Netherlands

Other Recalls by Mercury Enterprises, Inc. dba Mercury Medical

View all recalls by Mercury Enterprises, Inc. dba Mercury Medical →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.