Class 2 Device Recall GemStar

• Date Initiated by Firm: May 11, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on October 20, 2004
• Recall Number: Z-1077-04
• Recall Event ID: 29056
• Product Classification: Pump, Infusion - Product Code FRN
• Product: GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271
• Code Information: 95-156-5H, 05-027-5H, 09-208-5H
• Recalling Firm/ Manufacturer: Abbott Labs; 755 Jarvis Dr; Morgan Hill CA 95037-2810
• Manufacturer Reason for Recall: The firm's internal testing that revealed the potential air-in-line may go undetected when the set is used at temperatures above 25C (77 F).
• FDA Determined Cause: Other
• Action: Recall initiated May 11, 2004. Letters were sent to consignees and wholesalers.
• Quantity in Commerce: 18,432 units
• Distribution: Total number of consignees that received product: 13. Five are wholesale dealers, None are distributors, 8 are retailers. Product has been distributed worldwide, and in the United States: AR, Washington DC, FL, IL, KY, LA, MA, MD, MN, MO, NJ, TX. Also sent to National Institute of Health, Bethesda, MD, (301) 496-4000
• 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.