Recall Z-0004-2025 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Mercury Enterprises, Inc. dba Mercury Medical
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
| Date | Oct 2, 2024 (initiated Aug 30, 2024) |
| Status | Open, Classified |
| Reason | Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 1,300 units |
| Distribution | US distribution to MI, FL, SC, PA, IN. International distribution to Albania. |
| 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 |