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U.S. Department of Health and Human Services

Class 2 Device Recall Alta

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 Class 2 Device Recall Altasee related information
Date Initiated by FirmOctober 23, 2009
Date PostedNovember 17, 2009
Recall Status1 Terminated 3 on June 09, 2010
Recall NumberZ-0327-2010
Recall Event ID 53605
510(K)NumberK032061 K040509 K042858 K060155 K063431 K063441 
Product Classification Blood access device and accessories - Product Code MSD
Product24CM ALTA EXCHANGE KIT Model: AL19SH24-XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, 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 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 Commerce26 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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