Class 3 Device Recall MAQUET Bioline Connectors

• Date Initiated by Firm: February 23, 2011
• Date Posted: March 16, 2011
• Recall Status: Terminated on September 13, 2012
• Recall Number: Z-1666-2011
• Recall Event ID: 58053
• 510(K)Number: K080592
• Product Classification: Tubing, pump, cardiopulmonary bypass - Product Code DWE
• Product: Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16" x 3/16" Connectors, Lot 70041096. The HG 0284 and HG 1113 connectors are packaged sterile as single components in a container holding 20 units. The connectors are designed to be used for performing connections between tubes in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. BEQ-HG Connectors are to be used with MAQUET HLM Tubing sets.
• Code Information: BEQ-HG 0284 Connector 3/8" x 3/8" Lot 70041098; BEQ-HG 1113 Connector 3/16" x 3/16" Lot 70041096 (note that this code was in the connector mispackaged in the box)
• Recalling Firm/ Manufacturer: Maquet Cardiovascular, LLC; 45 Barbour Pond Dr; Wayne NJ 07470-2094
• For Additional Information Contact: Ms. Susan Mandy; 201-995-8782
• Manufacturer Reason for Recall: Tubing connectors incorrectly packaged and labeled.
• FDA Determined Cause: Other
• Action: The firm, Maquet, sent a "PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION" letter dated February 22, 2011 via Federal Express to its customer. The letter described the product, problem and the action to be taken. The customer was instructed to examine their inventory immediately to identify and remove the affected connectors and complete and return the attached RECALL- Device Corrective Action Response Form via fax to Director of Regulatory Affairs at (973) 709-7016 or email: whitney.torning@maquet.com. If you have any additional questions, please contact your local MAQUET Cardiovascular Sales Representative or customer service at 1-800-777-4222.
• Quantity in Commerce: 40 BEQ-HG 0284 3/8" x 3/8" Lot 70041098 Connectors
• Distribution: Nationwide distribution: USA state of CA.
• 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 = DWE