Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Dialysis tubing set

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Dialysis tubing setsee related information
Date Initiated by FirmOctober 24, 2005
Date PostedApril 05, 2006
Recall Status1 Terminated 3 on April 17, 2012
Recall NumberZ-0705-06
Recall Event ID 34080
510(K)NumberK032431 K980386 K981681 
Product Classification Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
ProductGambro 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
ActionRecall information was forwarded to all Gambro Sale Organizations. Notification was sent to all US consignees on November 2nd and November 3rd, 2005.
Quantity in Commerce28277 units
DistributionNationwide, 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 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 = KDI
510(K)s with Product Code = KDI
-
-