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U.S. Department of Health and Human Services

Class 2 Device Recall Dialysis tubing set

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  Class 2 Device Recall Dialysis tubing set see related information
Date Initiated by Firm October 24, 2005
Date Posted April 05, 2006
Recall Status1 Terminated 3 on April 17, 2012
Recall Number Z-0705-06
Recall Event ID 34080
510(K)Number K981681  K980386  K032431  
Product Classification Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
Product Gambro Prisma M100 preset, Part No. 8353486.
Code Information Lot numbers 04K2692P, 05A0754P, 05D1571, 05F0763A, 05F0865, 05F0966, 05F1573G, 05F1574, 05F1675G, 05F2387G, 05F3098G, 05G0556G, 05G0760G, 05G1366G. Recall expanded on 04/13/2006 to include 05AXXXXX through 05J2796P.
Recalling Firm/
Manufacturer		 Gambro Renal Products, Inc.
10810 W Collins Ave
Lakewood CO 80215-4439
For Additional Information Contact
303-231-4094
Manufacturer Reason
for Recall		 After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.
FDA Determined
Cause 2		 Other
Action Recall information was forwarded to all Gambro Sale Organizations. Notification was sent to all US consignees on November 2nd and November 3rd, 2005.
Quantity in Commerce 28277 units
Distribution Nationwide, including VA facilities in AZ, CA, DC, FL, GA, MI, MO, NJ, NY, OH, OR, PA, PR, TX, UT, VA, WI. Military distribution to CA and TX. Foreign distribution to Australia, Canada, Denmark, France, Germany, Hungary, UK.
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 = KDI and Original Applicant = GAMBRO HEALTHCARE
510(K)s with Product Code = KDI and Original Applicant = GAMBRO, INC.
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