FDA Medical devices recall ·
regard Item Number: 830106006, LD01114F - Newborn Kit containing the… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1047-2025
- Date
- (initiated December 26, 2024)
- Company / brand
- ROi CPS LLC
3000 E Sawyer Rd, Republic, MO, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 414 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
Why was it 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..
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
Distribution was made to MO. There was no government/military/foreign distribution.
States: Missouri
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1047-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.