Date Initiated by Firm |
October 23, 2009 |
Create Date |
November 17, 2009 |
Recall Status1 |
Terminated 3 |
Recall Number |
Z-0295-2010 |
Recall Event ID |
53605 |
Product |
28CM DECATHLON FUNNEL TIP STD KIT Model: DF23SH28
DECATHLON FUNNEL TIP 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/ Manufacturer |
Spire Biomedical, Inc. One Patriots Park Bedford MA 01730-2343
|
For Additional Information Contact |
Edward Rule 617-275-6000 Ext. 274
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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
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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. |
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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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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