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.
This recall has been terminated (originally issued January 15, 2019).
- Company
- Westmed Inc
- Recall Initiated
- January 15, 2019
- Terminated
- February 5, 2021
- Recall Number
- Z-2435-2020
- Quantity
- 35 cases
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
101618U02, 102318U06, 101518U03.
Root Cause
Device Design
Action Taken
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 the contact information provided. Reference numbers twill be provided to facilitate a return merchandise authorization (RMA). Contact info: Diana Upp at (520)294-7987 extension 1235 or Dean Iwasaki at extension 1132. Contact Information: Mail original signed documents to Regulatory Department at 5580 S. Nogales Hwy, Tucson AZ, 85706. Additionally, scan/email a copy of the documents to Diana Upp at dupp@westmedinc.com. Response is required; complete the Medical Device Recall Return Response Acknowledgement and Receipt Form Distributors are instructed to do the following: 1) Check stock and quarantine inventory. 2) Identify and notify customers that were shipped or may have been shipped product. 3) Attach a list of customers who received/may have received product. Customers of distributors to be notified.