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U.S. Department of Health and Human Services

Class 2 Device Recall Decathlon Funnel Tip

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  Class 2 Device Recall Decathlon Funnel Tip see related information
Date Initiated by Firm October 23, 2009
Date Posted November 17, 2009
Recall Status1 Terminated 3 on June 09, 2010
Recall Number Z-0295-2010
Recall Event ID 53605
510(K)Number K040509  K063441  K063431  K032061  K042858  K060155  
Product Classification Blood access device and accessories - Product Code MSD
Model: DF23SH28

15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and
apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator,
14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.
Code Information All lot codes
Recalling Firm/
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 1791 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.