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
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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. |
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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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