Date Initiated by Firm |
July 29, 2010 |
Date Posted |
September 25, 2010 |
Recall Status1 |
Terminated 3 on July 05, 2012 |
Recall Number |
Z-2494-2010 |
Recall Event ID |
56363 |
510(K)Number |
K810675
|
Product Classification |
Wire, Guide, Catheter - Product Code DQX
|
Product |
Arterial Catheterization Set |
Code Information |
Product # CK-04018, Lot No's: RF0019104 and RF0022537 |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Road Reading PA 19605
|
For Additional Information Contact |
Christine Richards 800-523-8446
|
Manufacturer Reason for Recall |
Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
|
FDA Determined Cause 2 |
Mixed-up of materials/components |
Action |
The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form. |
Quantity in Commerce |
9 |
Distribution |
The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe. |
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 = DQX and Original Applicant = ARROW INTL., INC.
|