Z-2434-2020 Class II Terminated
FDA device recall Z-2434-2020 was initiated by Westmed, Inc. on January 15, 2019 and is designated Class II. 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 … The recall status is terminated (terminated February 5, 2021). Affected quantity: 625 cases.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2020
- Initiation Date
- January 15, 2019
- Termination Date
- February 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 625 cases
Product Description
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.
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 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.
Code Information
101118T42, 101118T44, 102918T01, 080618T02, 080618T03 , 101118T43, 102918T02.