Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
FDA device recall Z-0004-2025 · posted 2024-10-02 · Open, Classified
Recall details
- Recalling firm
- Mercury Enterprises, Inc. dba Mercury Medical
- Reason for recall
- Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- BTL
- Quantity affected
- 1,300 units
- Distribution
- US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
- Date initiated
- 2024-08-30
- Date posted
- 2024-10-02
- Location
- Clearwater, FL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MERCURY MEDICAL T-PIECE RESUSCITATOR (K093913) | Mercury Medical, Inc. | 2010-04-06 |