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Neo-Tee T-Piece Resuscitator, for pediatric emergency… recallZ-0821-2025 · Mercury Enterprises, Inc. dba Mercury Medical · initiated Dec 10, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Mercury Enterprises, Inc. dba Mercury Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process change control

What the company is doing

On 12/10/2024, "URGENT: FIELD SAFETY NOTICE" letters were mailed and emailed to medical facilities and distributors who were asked to do the following: Medical Facilities/Distributors: 1) Users should cease use and distribution of affected product and immediately quarantine the affected product. 2) Contact firm's customer service department at [email protected] (Domestic) and [email protected] (International) to assist you on how to send the affected product back to the firm for product replacement or credit. 3) Please notify all personnel subject to using these devices. 4) Complete and return the response form via email to [email protected] In addition, distributors were asked to do the following: 5) Provide a copy of this recall notice to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you. If you have any questions regarding this action, contact the firm at 800-237-6418/727-573-0088, or e-mail at [email protected]

Recall details

Recall number
Z-0821-2025
Status
Open, Classified
Initiated by the company
Dec 10, 2024
Posted by the FDA
Jan 10, 2025
Recalling firm
Mercury Enterprises, Inc. dba Mercury Medical
Quantity
37370
Product code
BTL
FDA submissions
K093913
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

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

11 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

25 devices cleared under K093913 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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