Date Initiated by Firm |
April 11, 2008 |
Date Posted |
September 16, 2008 |
Recall Status1 |
Terminated 3 on October 28, 2008 |
Recall Number |
Z-1910-2008 |
Recall Event ID |
47856 |
510(K)Number |
K053345
|
Product Classification |
Long term greater than 30 days therapeutic Intravascular Catheter - Product Code LJS
|
Product |
USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product is shipped 5 units per box and is indicated for short and long term access to the central venous system. |
Code Information |
Lot number MAPA880 |
Recalling Firm/ Manufacturer |
Medical Components, Inc dba MedComp 1499 Delp Dr Harleysville PA 19438-2936
|
For Additional Information Contact |
Susan Smith, RN BSN 215-256-4201
|
Manufacturer Reason for Recall |
kit contains incorrect component
|
FDA Determined Cause 2 |
Mixed-up of materials/components |
Action |
The recalling firm issued recall letters on 4/11/08 via UPS delivery. The letters informed the customers of the problem and the need to return the product. |
Quantity in Commerce |
250 units |
Distribution |
The products were shipped to customers in PA and TX. |
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 = LJS and Original Applicant = MEDCOMP
|