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 Hemodialysis Clinical Kit

  • 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 Hemodialysis Clinical Kitsee related information
Date Initiated by FirmNovember 13, 2002
Create DateDecember 02, 2002
Recall Status1 Completed
Recall NumberZ-0307-03
Recall Event ID 25023
ProductGambro ClinicalKit Safety Kit 15G, Catalog Number 0141080405C. Packaged 30 kits per case. Each kit contains 2 Nipro Safetouch Safety Needles.
Code Information Gambro ClinicalKit Safety Kit 15G. Catalog No. 0141080405C. Lots 05H154001, 04H154007, 04H154010, 04H154011..
Recalling Firm/
Manufacturer		 Gambro Renal Products
10810 West Collins Ave.
Lakewood 80215
Manufacturer Reason
for Recall		Gambro's ClinicalKit 15G safety Kits contain the Nipro Safetouch Safety Fistula Needles currently being recalled by Nipro for leakage problems
ActionAll consignees were notified by telephone and fax on 11/13/2002.
Quantity in Commerce2,160 kits
DistributionDomestic distribution to CO, IL, MO and VA. No military, government or foreign consignees.
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.
-
-