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U.S. Department of Health and Human Services

Class 2 Device Recall Hemodialysis Clinical Kit

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  Class 2 Device Recall Hemodialysis Clinical Kit see related information
Date Initiated by Firm November 13, 2002
Create Date December 02, 2002
Recall Status1 Completed
Recall Number Z-0307-03
Recall Event ID 25023
Product Gambro ClinicalKit Safety Kit 16G, Catalog Number 0141080404C. Packaged 30 kits per case. Each kit contains 2 Nipro Safetouch Safety Needles.
Code Information Gambro ClinicalKit Safety Kit 16G. Catalog Number 0141080404C. Lot Number 04H154014.
Recalling Firm/
Manufacturer		 Gambro Renal Products
10810 West Collins Ave.
Lakewood 80215
Manufacturer Reason
for Recall		 Gambro's ClinicalKit 16G safety Kits contain the Nipro Safetouch Safety Fistula Needles currently being recalled by Nipro for leakage problems
Action All consignees were notified by telephone and fax on 11/13/2002.
Quantity in Commerce 9,510 kits
Distribution Domestic 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.
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