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U.S. Department of Health and Human Services

Class 2 Device Recall NeoVent Infant TPiece Resuscitation Circuit

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  Class 2 Device Recall NeoVent Infant TPiece Resuscitation Circuit see related information
Date Initiated by Firm January 15, 2019
Create Date June 26, 2020
Recall Status1 Terminated 3 on February 05, 2021
Recall Number Z-2436-2020
Recall Event ID 85576
510(K)Number K923618  
Product Classification Attachment, breathing, positive end expiratory pressure - Product Code BYE
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.
Code Information 101518U04, 102318U07, 101618U03.  
Recalling Firm/
Manufacturer		 Westmed, Inc.
5580 S Nogales Hwy Ste 170
Tucson AZ 85706-3333
For Additional Information Contact Dean Iwasaki
520-294-7987 Ext. 1132
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BYE and Original Applicant = INTERNATIONAL RESPIRATORY SYSTEMS, INC.
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