Class 2 Device Recall Clear PAY Connector

• Date Initiated by Firm: September 18, 2014
• Date Posted: November 06, 2014
• Recall Status: Terminated 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/ Manufacturer: Dokitz NovoSci; 2021 Airport Rd; Conroe TX 77301-3250
• For Additional Information Contact: 281-363-4949
• Manufacturer Reason for Recall: The single leg of the PAY connector has been observed to become detached.
• FDA Determined Cause: 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.