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U.S. Department of Health and Human Services

Class 2 Device Recall Gambro Cartridge Blood Set

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  Class 2 Device Recall Gambro Cartridge Blood Set see related information
Date Initiated by Firm December 09, 2013
Date Posted April 11, 2014
Recall Status1 Terminated 3 on December 22, 2015
Recall Number Z-1455-2014
Recall Event ID 67797
Product Classification Set, tubing, blood, with and without anti-regurgitation - Product Code FJK
Product Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.
Code Information Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553
Recalling Firm/
Manufacturer		 Gambro Renal Products, Incorporated
14143 Denver West Pkwy
Lakewood CO 80401-3266
For Additional Information Contact
303-232-6800
Manufacturer Reason
for Recall		 Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
FDA Determined
Cause 2		 Process control
Action On 12/9/13 and 3/12/14, a field safety notice sent via UPS overnight delivery informing customers of issue and if any customer wants to return product, a hold at distribution centers and manufacturer quarantine areas. Upon reconciliation of returned product a destruction disposition with certification.
Quantity in Commerce 306,525 sets (20435 boxes of 15 sets)
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
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.
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