Date Initiated by Firm |
October 23, 2009 |
Date Posted |
November 17, 2009 |
Recall Status1 |
Terminated 3 on June 09, 2010 |
Recall Number |
Z-0301-2010 |
Recall Event ID |
53605 |
510(K)Number |
K040509 K063441 K063431 K032061 K042858 K060155
|
Product Classification |
Blood access device and accessories - Product Code MSD
|
Product |
28CM DECATHLON FUNNEL TIP CATHETER Model: DF23SH28-100
DECATHLON FUNNEL TIP - CATHETER ONLY 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Latex free. |
Code Information |
All lot codes |
Recalling Firm/ Manufacturer |
Spire Biomedical, Inc. One Patriots Park Bedford MA 01730-2343
|
For Additional Information Contact |
Edward Rule 617-275-6000 Ext. 274
|
Manufacturer Reason for Recall |
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira
|
FDA Determined Cause 2 |
Process control |
Action |
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635. |
Quantity in Commerce |
99 units |
Distribution |
Worldwide distribution - Nationwide, Government. Foreign: Canada, France. |
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 = MSD and Original Applicant = SPIRE BIOMEDICAL INC 510(K)s with Product Code = MSD and Original Applicant = SPIRE BIOMEDICAL, INC.
|