| Class 2 Device Recall Maquet Coronary Perfusion Cannulae with Balloon Tip | |
Date Initiated by Firm | May 19, 2009 |
Date Posted | August 31, 2009 |
Recall Status1 |
Terminated 3 on December 21, 2010 |
Recall Number | Z-1869-2009 |
Recall Event ID |
52663 |
Product Classification |
Coronary Perfusion Cannulae - Product Code DWF
|
Product | Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straight or right angle, available with proximal end fittings for either 1/4 inch connector or male luer fitting, Model numbers 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804, 215805, 215806, 215807, 215810, 215811, 215812, 215813, 215814, 215815, 215816, and 215817. |
Code Information |
Manufacturing lot numbers 272809 to 278615 and 70000241 to 70024294, Model numbers 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804, 215805, 215806, 215807, 215810, 215811, 215812, 215813, 215814, 215815, 215816, and 215817. |
Recalling Firm/ Manufacturer |
Maquet Cardiovascular 170 Baytech Dr San Jose CA 95134-2302
|
For Additional Information Contact | 408-635-6874 |
Manufacturer Reason for Recall | Undeclared allergen: Products are missing the warning label declaring that the products contain natural rubber latex. |
FDA Determined Cause 2 | Process control |
Action | Maquet Cardiovascular issued a notification letter to consignees on May 19, 2009. |
Quantity in Commerce | 2,226 devices |
Distribution | Nationwide distribution. |
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.
|
|
|
|