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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 Decathlon 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-0289-2010
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 STD KIT
Models: DE23SH28 and DE23SH28-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis.
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 10199 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.
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