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U.S. Department of Health and Human Services

Class 2 Device Recall Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj sites, 0.2um Filter, Pressure limited check

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  Class 2 Device Recall Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj sites, 0.2um Filter, Pressure limited check see related information
Date Initiated by Firm November 24, 2009
Date Posted January 26, 2010
Recall Status1 Terminated 3 on February 14, 2011
Recall Number Z-0674-2010
Recall Event ID 53955
510(K)Number K942988  
Product Classification Intravascular administration set - Product Code FPA
Product Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj sites, 0.2um Filter, Pressure limited check valve 119 in US3169F
Code Information Product code 352442. Lot numbers: 61031831 exp 2/28/2012, 61031834 exp 3/31/2012, 61047683 exp 4/30/2012, 61047686 exp 5/31/2012, 61057493 exp 6/30/2012, 61057494 exp 6/30/2012, and 61057499 exp 7/31/2012.
Recalling Firm/
B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown PA 18109-9512
For Additional Information Contact Scott Haff
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 2
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 83976 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 and Original Applicant = B. BRAUN OF AMERICA, INC.