regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

Class I - Dangerous

🏥 Medical Devices Recalled: December 26, 2024 ROi CPS Infusion Pumps

What Should You Do?

Check if you have this product:
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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: ROi CPS LLC
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..
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

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.