Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 105
Summary
The FDA issued a Class I for Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: by Mercury Enterprises, Inc. dba Mercury Medical. Reason: Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the hi.
Details
Source
Device Recall
External ID
Z-0821-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
Lot/Code Info: Part/UDI-DI/Lot: 1050805/10641043508053, 30641043508057/2421450805, 2423550805, 2423650805, 2426750805; 1050808/10641043508084, 30641043508088/2426450808, 2426750808, 2426850808, 2429050808, 2429350808; 1050809/10641043508091, 30641043508095/2426450809, 2426750809, 2429050809, 2429150809, 2429350809, 2429750809, 2429850809, 2430050809, 2430250809; 1050810 /10641043508107, 30641043508101/2426750810, 2429350810, 2429750810, 2429850810, 2430250810; 1050811/10641043508114, 30641043508118/2426550811, 2426650811, 2426750811, 2429050811, 2429150811, 2429250811, 2429350811, 2429450811, 2429750811, 2429850811, 2429950811, 2430250811; 1050814/10641043508145, 30641043508149/2426450814, 2426750814, 2429050814, 2429750814, 2430250814; 1050832/10641043508329, 30641043508323/2429050832, 242985083; 1050839/10641043508398, 30641043508392/2430350839; 1050840/10641043508404, 30641043508408/2429050840, 2429750840; 1050841/10641043508411, 30641043508415/2429050841; 1050842/10641043508428, 30641043508422/2426750842
Quantity Affected: 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.
Distribution
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-10
Company
Clearwater, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mercury Enterprises, Inc. dba Mercury Medical has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mercury Enterprises, Inc. dba Mercury Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mercury Enterprises, Inc. dba Mercury Medical have FDA actions?
Mercury Enterprises, Inc. dba Mercury Medical has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0821-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29