Class 2 Device Recall Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pressure Limited Check

• Date Initiated by Firm: November 24, 2009
• Date Posted: January 26, 2010
• Recall Status: Terminated on February 14, 2011
• Recall Number: Z-0703-2010
• Recall Event ID: 53955
• 510(K)Number: K904518
• Product Classification: Intravascular administration set - Product Code FPA
• Product: Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pressure Limited Check Valve 134 in
• Code Information: Product Code NF3140. Lot numbers: 61040801 exp 2/28/2012, 61040802 exp 2/28/2012, 61040803 exp 2/28/2012, 61040804 exp 3/30/2012, 61040805 exp 3/30/2012, 61040806 exp 3/30/2012, 61044303 exp 3/30/2012, 61044304 exp 4/30/2012, 61049787 exp 4/30/2012, 61049790 exp 4/30/2012, 61049793 exp 4/30/2012, 61049794 exp 4/30/2012, 61049795 exp 5/31/2012, 61049796 exp 5/31/2012, 61049797 exp 5/31/2012, 61049798 exp 5/31/2012, 61049799 exp 5/31/2012, 61049800 exp 5/31/2012, 61049801 exp 5/31/2012, 61057015 exp 6/30/2012, 61057016 exp 6/30/2012, 61057017 exp 6/30/2012, 61057018 exp 6/30/2012, 61057019 exp 6/30/2012, 61057200 exp 6/30/2012, 61057201 exp 7/30/2012, 61072172 exp 7/30/2012, 61072173 exp 7/30/2012, 61072174 exp 7/30/2012, and 61072175 exp 7/30/2012.
• Recalling Firm/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Boulevard; Allentown PA 18109-9512
• For Additional Information Contact: Scott Haff; 610-266-0500
• Manufacturer Reason for Recall: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the set to be used. This requires a new set to be obtained, thus creating a potential for delay in therapy.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recalling firm issued a Product Removal Notice via US Postal Service Certified Mail with registered return receipt or FedEx to all customers and distributors in receipt of the affected product. The notices were sent 11/30/09 and 12/1/09. Direct customers also received letters addressed to Material Management that informed them of the recall and provided instruction for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers. Questions are directed to the company's Customer Support Departments: US customers please call (800) 227-2862. Canadian customers, please call (800) 624-2920. International customers, please call (610) 691-5400.
• Quantity in Commerce: 446813 units
• Distribution: The products were shipped to distributors and medical facilities nationwide. The product was also shipped to Afghanistan, Canada and LU.
• 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 = FPA