Date Initiated by Firm | October 23, 2009 |
Date Posted | November 17, 2009 |
Recall Status1 |
Terminated 3 on June 09, 2010 |
Recall Number | Z-0293-2010 |
Recall Event ID |
53605 |
510(K)Number | K032061 K040509 K042858 K060155 K063431 K063441 |
Product Classification |
Blood access device and accessories - Product Code MSD
|
Product | 55CM DECATHLON STD KIT
Models: DE50SH55 and DE50SH55-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
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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 | 828 units |
Distribution | Worldwide distribution - Nationwide, Government. Foreign: Canada, France. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MSD 510(K)s with Product Code = MSD
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