Date Initiated by Firm |
May 22, 2007 |
Date Posted |
July 10, 2007 |
Recall Status1 |
Terminated 3 on July 07, 2009 |
Recall Number |
Z-0882-2007 |
Recall Event ID |
37996 |
510(K)Number |
K063618
|
Product Classification |
Arterial Cannulae - Product Code DWF
|
Product |
Terumo TenderFlow Pediatric Arterial Cannulae, 4.7 mm (14Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813575. |
Code Information |
Lot 2120270. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corp 6200 Jackson Rd Ann Arbor MI 48103-9586
|
For Additional Information Contact |
800-521-2818
|
Manufacturer Reason for Recall |
The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified via phone beginning on 5/22/07 and by follow-up letters sent between 5/23/07 and 6/14/07. |
Quantity in Commerce |
52 |
Distribution |
Nationwide. |
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 = TERUMO CARDIOVASCULAR SYSTEMS CORP.
|