Date Initiated by Firm |
November 05, 2014 |
Date Posted |
December 24, 2014 |
Recall Status1 |
Terminated 3 on July 24, 2015 |
Recall Number |
Z-0870-2015 |
Recall Event ID |
69795 |
510(K)Number |
K100278
|
Product Classification |
Oxygenator, cardiopulmonary bypass - Product Code DTZ
|
Product |
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000
For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature. |
Code Information |
k100278 Lot number 70100610 |
Recalling Firm/ Manufacturer |
Maquet Cardiovascular Us Sales, Llc 45 Barbour Pond Drive Wayne NJ 07470
|
For Additional Information Contact |
888-627-8383
|
Manufacturer Reason for Recall |
Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are labeled correctly with the Bioline coating, the individual cartons and 4-pack shipping containers of this lot incorrectly bear Softline coating labels instead of the bioline coating labels.
|
FDA Determined Cause 2 |
Process control |
Action |
Maquet Inc. sent Urgent Product Recall - Removal Letters/Response Forms dated 11/5/2014. |
Quantity in Commerce |
28 units |
Distribution |
Distributed in DC, MA, & MI. |
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 = DTZ and Original Applicant = MAQUET CARDIOPULMONARY AG
|