FDA issues Class I recall on newborn resuscitation devices

Chad Van Alstin | | Health Exec | Supply Chain
Recall

The U.S. Food and Drug Administration (FDA) is alerting the public to a recall of a line of gas-powered resuscitator devices used on newborns. An undersized spring in the controller could prevent the system from delivering effective ventilation. The Neo-Tee T-Piece Resuscitators are sold in kits and are intended for use with pediatric patients weighing less than 22 lbs.

The manufacturer, ROi CPS, announced the recall after receiving an urgent safety notice from one of its suppliers, Mercury Medical. While there have been no reported injuries, given the risk of serious breathing difficulties and potentially death, the recall has been classified as a Class I recall, the most serious FDA designation.

What is being recalled?

The products are sold as ROi Regard Newborn Kits. Defective devices are associated with the below lot and Unique Device Identification (UDI) numbers:

  • Lot number 104006, Exp. 9/30/2026, UDI (01)10194717119074(17)260930(10)104006
  • Lot number 103486, Exp. 8/31/2026, UDI (01)10194717119074(17)260831(10)103486

Next Steps

All affected products must not be used, and distribution of the kits must cease immediately. ROi notified known customers of the issue in a letter sent on Dec. 26, 2024. However, both the company and the FDA are requesting the recall notice be shared to aid in the removal of the Regard Newborn Kits from the supply.

Anyone with one of the systems is asked to quarantine it immediately. Providers in possession of any of the recalled items should initiate a return with their distributor.

Any unreported issues should be submitted to the FDA MedWatch program immediately.

The full notice can be found here.

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FDA issues Class I recall of brain fluid drain kits after 15 injuries
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Chad Van Alstin Health Imaging Health Exec
Chad Van Alstin

Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.

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