| Class 2 Device Recall Peripherally inserted central catheter. | |
Date Initiated by Firm | March 25, 2005 |
Date Posted | December 15, 2005 |
Recall Status1 |
Terminated 3 on August 08, 2011 |
Recall Number | Z-0285-06 |
Recall Event ID |
31670 |
510(K)Number | K920755 |
Product Classification |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
|
Product | 16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte |
Code Information |
REF 384426 |
Recalling Firm/ Manufacturer |
Becton Dickinson Medical Systems 9450 S State St Sandy UT 84070-3213
|
For Additional Information Contact | 801-565-2341 |
Manufacturer Reason for Recall | Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified via telephone and fax letter, beginning 04/25/2005. |
Quantity in Commerce | 5740 units |
Distribution | AL, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NJ, OH, OK, PA, TN, TX, WA. No Government or military consignees. Foreign distribution to Australia, Canada, Japan. |
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
|
|
|
|