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Class 2 Device Recall Gambro Prismaflex |
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Date Initiated by Firm |
January 04, 2007 |
Date Posted |
March 31, 2007 |
Recall Status1 |
Terminated 3 on January 03, 2012 |
Recall Number |
Z-0695-2007 |
Recall Event ID |
37306 |
510(K)Number |
K041005
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Product Classification |
Hemodialysis machine - Product Code KDI
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Product |
Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden. |
Code Information |
Serial numbers: PA0101 thru PA0681, PA1001 thru PA1774. |
Recalling Firm/ Manufacturer |
Gambro Renal Products, Inc. 10810 W Collins Ave Lakewood CO 80215-4439
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For Additional Information Contact |
Tom Dowell 800-525-2623
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Manufacturer Reason for Recall |
Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)
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FDA Determined Cause 2 |
Device Design |
Action |
Customers were notified by letter on 12/19/2006. They were told that Gambro would schedule the required upgrades to their equipment and not to use the current syringe for delivering anticoagulant. |
Quantity in Commerce |
153 units (Domestic) |
Distribution |
Nationwide distribution -- including states of AL, CA, FL, GA, IN, MD, ME, MI, MS, NC, NH, NY, OH, PA, SC, TX, VA, and WI. |
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 = KDI and Original Applicant = GAMBRO RENAL PRODUCTS
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