|
Class 2 Device Recall Arrow |
|
Date Initiated by Firm |
September 29, 2006 |
Date Posted |
December 19, 2006 |
Recall Status1 |
Terminated 3 on June 04, 2007 |
Recall Number |
Z-0285-2007 |
Recall Event ID |
36522 |
510(K)Number |
K926011 K921379
|
Product Classification |
Implantable Vascular Access System - Product Code LJT
|
Product |
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A Port. 6 Fr. Introducer Kit. Ref Product No. AP-06014 |
Code Information |
Product No. AP-06014. Lot Numbers: 12130, 12134, MF3074955, MF3075069, MF3116186,MF3116232, MF3126390, MF4020623, MF4073774, MF4094578, MF4094703, MF4126653, MF5049105,MF5050037, MF5092675, MF5103680, MF6014995, MF6079156, MF6089978. |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605-9607
|
For Additional Information Contact |
Paul Cornelison 610-378-0131
|
Manufacturer Reason for Recall |
Catheter has separated from the infusion port body.
|
FDA Determined Cause 2 |
Other |
Action |
The recall notification was sent out to their US customers on 9/29/2006. |
Quantity in Commerce |
94 |
Distribution |
Nationwide. The firm is NOT recalling from international accounts. |
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 = LJT and Original Applicant = THEREX CORP.
|
|
|
|