Class 2 Device Recall

• Date Initiated by Firm: March 21, 2006
• Date Posted: May 17, 2006
• Recall Status: Terminated on December 07, 2006
• Recall Number: Z-0870-06
• Recall Event ID: 34961
• 510(K)Number: K914988
• Product Classification: Infusion pump - Product Code FRN
• Product: ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical Corporation, Neptune, NJ.
• Code Information: All Serial Numbers since 1996.
• FEI Number: 1000122362
• Recalling Firm/ Manufacturer: Excelsior Medical Corp; 1923 Heck Ave; Neptune NJ 07753-4428
• For Additional Information Contact: Himanshu Naik; 732-643-6080
• Manufacturer Reason for Recall: Potential for alarm failure when the 140 pump completes infusion and/or the pump encounters a mid-infusion occlusion, when used in the 140 mode with a 140cc syringe. The ESP Pump works correctly when used in 60 mode with a 60cc syringe or smaller.
• FDA Determined Cause: Other
• Action: An 'Urgent Recall' letter was mailed certified return receipt mail on 3/22/06 to all customers per distribution list.
• Quantity in Commerce: 3911 units
• Distribution: Nationwide and Quebec, Canada
• 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.

• 510(K) Database: 510(K)s with Product Code = FRN