Date Initiated by Firm |
February 03, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on June 10, 2004 |
Recall Number |
Z-0586-04 |
Recall Event ID |
28397 |
510(K)Number |
K974764
|
Product Classification |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
|
Product |
BD First PICC Introsyte-N, 1.9Fr. x 50cm Single Lumen Procedure Kit. |
Code Information |
Catalog Number 384224, Lot Number 3349840. |
Recalling Firm/ Manufacturer |
Becton Dickinson Infusion Therapy 9450 South State Street Sandy UT 84070
|
For Additional Information Contact |
801-565-2341
|
Manufacturer Reason for Recall |
Splittable catheter introducer may not fully split or may separate non-uniformly.
|
FDA Determined Cause 2 |
Other |
Action |
On 02/03/2004, all consignees were notified by telephone and letter. |
Quantity in Commerce |
1560 kits |
Distribution |
Nationwide. Foreign distribution to Australia and Brazil. No government or military direct accounts. |
Total Product Life Cycle |
TPLC Device Report
|
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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 = FOZ and Original Applicant = BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
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