Recall Z-2435-2020 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
Westmed, Inc.
Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only.
| Date | Jan 15, 2019 |
| Status | Terminated |
| Reason | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not being able to use those circuits. |
| Root cause | Device Design |
| Action | The firm sent a notification letter via email and it was issued on 1/15/2019. The following are actions given by the recalling firm to be taken by the customer/user: 1. If you are using the Neo-Vent Circuit with a 10 mm ID connection system (such as the F&P Neopuff System) the connection is compatible with all product lots. You may continue to use it with no issues. 2. If you are using the Neo-Vent Circuit with a 15 mm OD connection system (such as the GE Panda or Giraffe System), the connection may not be compatible with the list of LOT numbers. Quarantine the product and contact via |
| Quantity | 35 cases |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, GA, IL,OH, MA, MI, MO, NC, OH, OR, TX, VA, and WI. The country of Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923618 | PEEP VALVE International Respiratory Systems, Inc., Aug 3, 1992 |