Z-1047-2025 Class I Ongoing
FDA device recall Z-1047-2025 was initiated by ROi CPS LLC on December 26, 2024 and is designated Class I. Reason for recall: 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 h… The recall status is ongoing. Affected quantity: 414 kits.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2025
- Initiation Date
- December 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 414 kits
Product Description
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
Reason for Recall
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..
Distribution Pattern
Distribution was made to MO. There was no government/military/foreign distribution.
Code Information
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.