|
Class 2 Device Recall Medline Open Heart CDS Kit |
|
Date Initiated by Firm |
March 18, 2005 |
Date Posted |
April 27, 2005 |
Recall Status1 |
Terminated 3 on October 17, 2005 |
Recall Number |
Z-0769-05 |
Recall Event ID |
31528 |
Product Classification |
General Surgery Tray - Product Code LRO
|
Product |
Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian Nexus Unilimb Rebreathing Circuit, part 40301-1-30, among other components needed for open heart surgery; Made in USA by Medline Industries, Inc., Mundelein, IL 60060 |
Code Information |
reorder number CDS840144A, lots 04JD2847, 04LD2995, 05AD3946, 05BD0929, 05BD4100 |
Recalling Firm/ Manufacturer |
Medline Industries, Inc. 1170 S Northpoint Blvd Waukegan IL 60085-6757
|
For Additional Information Contact |
Ms. Lara M. Simmons 800-879-2791 Ext. 6072
|
Manufacturer Reason for Recall |
The procedure packs contain anesthesia/breathing circuits being recalled by MMS Sales due to partial occlusion of the T-piece resulting in airway obstruction.
|
FDA Determined Cause 2 |
Other |
Action |
Recalled from the direct account hospitals via letter dated 3/18/05 and 3/23/05. The letters informed the accounts of the occlusion via copy of the MMS recall letter, and listed the Medline reorder number and lot numbers of the custom packs shipped to them, along with the MMS part number contained there in. The accounts were requested to examine their stocks for the affected codes and return them to Medline. |
Quantity in Commerce |
116 kits |
Distribution |
California, Alabama, Minnesota, Florida and Indiana. |
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.
|
|
|
|