Z-1047-2025Class I

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator...

Name: Z-1047-2025 regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator...
Creator: ROi CPS LLC
Published: 2024-12-26
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2024-12-26 / Open, Classified / root cause: manufacturing process

FDA source

ROi CPS LLC began a recall of regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery on 2024-12-26. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1047-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-12-26
Posted: 2025-02-04
Recalling firm: ROi CPS LLC
Product: regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
Product code: MLS Labor And Delivery Kit
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..
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 12/26/2024, the recalling firm issued a notice dated 12/26/2024 via email to their sole consignee notifying them of the recall of the convenience kits. The email also contained the notice issued by the manufacturer of the affected device component. The recalling firm's notice explained the reason for recall, the health risk involved, and the actions to be taken by the consignee, which included: (1) CHECK: Please review your inventory to determine if the manufacturer item numbers and lot numbers listed in the above table are in your inventory. (2) QUARANTINE: Please quarantine the kits affected by this notice and do not further distribute to end user facilities. (3) NOTIFY: Immediately notify any customers to whom you have distributed or forwarded product affected by this medical device correction notice. Provide a copy of this notice to all customers who have received impacted product and require a response. Customer responses will be requested to determine effectiveness of this recall. (4) END USERS: End users are instructed to discontinue use of the affected kits and quarantine. Kits are to be returned to the distribution location. (5) REPLY: Reply to this notice by completing the reply form attached and emailing to [email protected]. (6) CORRECTION: ROi CPS, LLC personnel will conduct correction activities at the distribution location to ensure removal of the recalled Mercury Medical item. The enclosed reply form is for the consignee to report they have read and understand the attached notice. The consignee is to indicate whether they have forwarded the notice to all customers who have been shipped the affected product, whether or not they have the consignee has the affected product, and that they have completed the "Quantity on Hand" portion of the reply form.
Quantity in commerce: 414 kits
Distribution: Distribution was made to MO. There was no government/military/foreign distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1047-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1047-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-02-12	2025-02-04

Product code MLS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)