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U.S. Department of Health and Human Services

Class 2 Device Recall Clear PAY Connector

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  Class 2 Device Recall Clear PAY Connector see related information
Date Initiated by Firm September 18, 2014
Date Posted November 06, 2014
Recall Status1 Terminated 3 on May 15, 2015
Recall Number Z-0178-2015
Recall Event ID 69535
510(K)Number K801404  
Product Classification Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
Product Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
Code Information Model No. 321334-000, lot number 295424
Recalling Firm/
Dokitz NovoSci
2021 Airport Rd
Conroe TX 77301-3250
For Additional Information Contact
Manufacturer Reason
for Recall
The single leg of the PAY connector has been observed to become detached.
FDA Determined
Cause 2
Process control
Action The recalling firm notified the affected customers via letter and requested the affected lot be returned to NovoSci.
Quantity in Commerce 240 units
Distribution MO, TX, PA, IL, MD, UT
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 = DTL and Original Applicant = TEXAS MEDICAL PRODUCTS, INC.