Date Initiated by Firm |
December 07, 2006 |
Date Posted |
February 27, 2007 |
Recall Status1 |
Terminated 3 on December 05, 2007 |
Recall Number |
Z-0544-2007 |
Recall Event ID |
37104 |
510(K)Number |
K930620
|
Product Classification |
arterial perfusion cannulae - Product Code DWF
|
Product |
Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula, 12 FR, 17.5 cm (7'') long; Catalog no. L7351. |
Code Information |
Lot 2119905, exp. October 2009. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corp 6200 Jackson Rd Ann Arbor MI 48103-9586
|
For Additional Information Contact |
800-262-3304
|
Manufacturer Reason for Recall |
The cannula connector is an incorrect size: It is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4".
|
FDA Determined Cause 2 |
Other |
Action |
Consignee was notified via telephone on 12/7/06 and returned the product. |
Quantity in Commerce |
10 |
Distribution |
Pennsylvania. |
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 = DWF and Original Applicant = C.R. BARD, INC.
|