Recall Z-1047-2025 ยท MLS Labor And Delivery Kit
ROi CPS LLC
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
| Date | Feb 4, 2025 (initiated Dec 26, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 af |
| Quantity | 414 kits |
| Distribution | Distribution was made to MO. There was no government/military/foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.