Device product
Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only.
Z-2434-2020
Product summary
- Firm
- Westmed, Inc.
- Event
- Event 85576
- Status
- Terminated
- Classification
- Class II
- Quantity
- 625 cases
- Official record key
device-enforcement:Z-2434-2020
Official wording
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.
Code information: 101118T42, 101118T44, 102918T01, 080618T02, 080618T03 , 101118T43, 102918T02.
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.