Recall Z-0821-2025 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Mercury Enterprises, Inc. dba Mercury Medical
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
| Date | Jan 10, 2025 (initiated Dec 10, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process change control |
| Action | 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 uscustomerservice@mercurymed.com (Domestic) and InternationalCustomerService@mercurymed.com (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 |
| Quantity | 37370 |
| 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, Cana |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093913 | MERCURY MEDICAL T-PIECE RESUSCITATOR Mercury Medical, Inc., Apr 6, 2010 |