Class 2 Device Recall Excelsior Medical

• Date Initiated by Firm: June 05, 2014
• Date Posted: July 16, 2014
• Recall Status: Terminated on August 19, 2015
• Recall Number: Z-2070-2014
• Recall Event ID: 68573
• 510(K)Number: K913804
• Product Classification: Set, i.V. Fluid transfer - Product Code LHI
• Product: Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer
• Code Information: Product Code PA03 - Lot Nos.: 03030813, 03050813 and 03091213 Product Code BX03, Lot Nos.: 64031513, 64073113, 64081313, 64090513
• Recalling Firm/ Manufacturer: Excelsior Medical Corp; 1933 Heck Ave; Neptune NJ 07753
• For Additional Information Contact: Mr. John M. Linfante; 800-487-4276
• Manufacturer Reason for Recall: There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Excelsior Medical issued "Urgent Medical Device Recall" notifications/"Customer Reply Forms" dated June 5, 2014 to affected customers via certified mail (return receipt request). The notice informed customers of the issue with the affected product; how to identify affected product; instructed the customers to discontinue use of tubing sets from the affected lots and return the attached form (Customer Reply Form) via fax to Excelsior to make arrangements for return of product. If product was further distributed by the customer the notification instructs them to identify the customer(s) that it was supplied to and notify them at once of the product recall. A phone number was provided in case customers had questions regarding the recall (1.800.487.4276 8:30 am - 5:00 pm EST) as well as an email address (recall12@excelsiormedical.com).
• Quantity in Commerce: 4250 tubing sets (PA03 - 78 cases; BX03 - 92 cases (each case contains 25 tubing sets))
• Distribution: Worldwide Distribution - USA (nationwide) and 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 = LHI