regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
Reported: February 12, 2025 Initiated: December 26, 2024 #Z-1047-2025
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..
Details
- Recalling Firm
- ROi CPS LLC
- Units Affected
- 414 kits
- Distribution
- Distribution was made to MO. There was no government/military/foreign distribution.
- Location
- Republic, MO
Frequently Asked Questions
What product was recalled? ▼
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.. Recalled by ROi CPS LLC. Units affected: 414 kits.
Why was this product recalled? ▼
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..
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2025. Severity: Critical. Recall number: Z-1047-2025.
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