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U.S. Department of Health and Human Services

Class 2 Device Recall Decathlon

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 Class 2 Device Recall Decathlonsee related information
Date Initiated by FirmOctober 23, 2009
Date PostedNovember 17, 2009
Recall Status1 Terminated 3 on June 09, 2010
Recall NumberZ-0305-2010
Recall Event ID 53605
510(K)NumberK032061 K040509 K042858 K060155 K063431 K063441 
Product Classification Blood access device and accessories - Product Code MSD
Product32CM DECATHLON MINI KIT Model: DM27SH32 DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge intro
Code Information All lot codes
Recalling Firm/
Manufacturer		 Spire Biomedical, Inc.
One Patriots Park
Bedford MA 01730-2343
For Additional Information ContactEdward 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
ActionSpire 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 Commerce77 units
DistributionWorldwide distribution - Nationwide, Government. Foreign: Canada, France.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MSD
510(K)s with Product Code = MSD
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