FDA Device recall Z-1047-2025
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator
- FDA Device
- Class I
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class I recall of regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator by Roi Cps, citing there is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1047-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-12-26 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Roi Cps |
| Distribution | MO |
Product
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
Reason
There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..
Identifiers
| code_info | Lot number 104006, Exp. 9/30/2026, UDI (01)10194717119074(17)260930(10)104006; and Lot number 103486, Exp. 8/31/2026, U…Lot number 104006, Exp. 9/30/2026, UDI (01)10194717119074(17)260930(10)104006; and Lot number 103486, Exp. 8/31/2026, UDI (01)10194717119074(17)260831(10)103486. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1047-2025%22
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