Recall Z-2435-2020— Westmed, Inc.
Class II · Terminated
Class II FDA medical device recall by Westmed, Inc., initiated 2019-01-15, terminated 2021-02-05. It names one FDA 510(k) clearance: K923618. Product: 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.. 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..
- Recalling firm
- Westmed, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-01-15
- Terminated
- 2021-02-05
- Firm location
- Tucson, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.