Date Initiated by Firm |
September 07, 2010 |
Date Posted |
October 06, 2010 |
Recall Status1 |
Terminated 3 on September 25, 2012 |
Recall Number |
Z-0011-2011 |
Recall Event ID |
56728 |
510(K)Number |
K080592
|
Product Classification |
Tubing, pump, cardiopulmonary bypass - Product Code DWE
|
Product |
MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400 |
Code Information |
Lot number 70052718 and 70048867 |
Recalling Firm/ Manufacturer |
Maquet Inc. 45 Barbour Pond Drive Wayne NJ 07470
|
For Additional Information Contact |
Ms. Susan Mandy 973-995-8968
|
Manufacturer Reason for Recall |
Tubing packs may contain defective 1/2 inch x 1/2 inch tubing connectors. Leaks at the shank of the connector may result in air aspiration in the venous line.
|
FDA Determined Cause 2 |
Device Design |
Action |
Maquet Getigne Group issued Product Recall/Urgent Medical Device Corrective Action letters dated September 7, 2010 to customers, identifying the affected product, the issue prompting the recall, and actions to be taken by customers.Customers are to check their inventory for affected product. Customers with affected product are to contact Laura Olilver at 201-995-8849 for an RMA number and shipment instructions. All firms are to coomplete and return the Corrective Action Response Form.
Maquet Customer Service can bre contacted at 800-777-4222. |
Quantity in Commerce |
22 items |
Distribution |
Worldwide Distribution: USA State of IL and country of the Netherlands. |
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 and Original Applicant = MAQUET CARDIOPULMONARY AG
|