Z-2436-2020Class II

Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant...

Name: Z-2436-2020 Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant...
Creator: Westmed, Inc.
Published: 2019-01-15
License: https://open.fda.gov/license/

Westmed Inc / initiated 2019-01-15 / Terminated / root cause: design

FDA source

Westmed, Inc. began a recall of Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421... on 2019-01-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2436-2020
Classification: Class II
Status: Terminated
Initiated: 2019-01-15
Posted: 2020-06-26
Terminated: 2021-02-05
Recalling firm: Westmed Inc
Product: Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.
Product code: BYE Attachment, Breathing, Positive End Expiratory Pressure
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.
Root cause tag: design
FDA 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 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 [email protected]. 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.
Quantity in commerce: 48 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.
Product codes and lots: 101518U04, 102318U07, 101618U03.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2436-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2434-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2435-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26
Z-2436-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26

Product code BYE

K923618Class IIPEEP ValveInternational Respiratory Systems, Inc. / cleared 1992-08-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)