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U.S. Department of Health and Human Services

Class 2 Device Recall Outlook Pump Set w/Universal Spike, 3 Ultrasite Inj Sites, Spin Lock Con & Pressure, Limited Check V

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  Class 2 Device Recall Outlook Pump Set w/Universal Spike, 3 Ultrasite Inj Sites, Spin Lock Con & Pressure, Limited Check V 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-0685-2010
Recall Event ID 53955
510(K)Number K955585  
Product Classification Intravascular administration set - Product Code FPA
Product Outlook Pump Set w/Universal Spike, 3 Ultrasite Inj Sites, Spin Lock Con & Pressure, Limited Check Valve, 134 in US3140
Code Information Product Code 375196. Lot numbers: 61044265 exp 2/28/2012, 61044267 exp 2/28/2012, 61044278 exp 2/28/2012, 61044279 exp 2/28/2012, 61044280 exp 2/28/2012, 61044281 exp 2/28/2012, 61044282 exp 2/28/2012, 61044283 exp 2/28/2012, 61044285 exp 3/31/2012, 61049092 exp 3/31/2012, 61049093 exp 3/31/2012, 61049095 exp 3/31/2012, 61049097 exp 3/31/2012, 61049108 exp 3/31/2012, 61049109 exp 3/31/2012, 61049110 exp 3/31/2012, 61049111 exp 3/31/2012, 61049113 exp 3/31/2012, 61049119 exp 3/31/2012, 61049123 exp 3/31/2012, 61049124 exp 3/31/2012, 61049125 exp 3/31/2012, 61049126 exp 4/30/2012, 61049127 exp 4/30/2012, 61049130 exp 4/30/2012, 61049131 exp 4/30/2012, 61049132 exp 4/30/2012, 61049133 exp 4/30/2012, 61049135 exp 4/30/2012, 61049137 exp 4/30/2012, 61049139 exp 4/30/2012, 61049140 exp 4/30/2012, 61049141 exp 4/30/2012, 61049143 exp 4/30/2012, 61049144 exp 4/30/2012, 61051044 exp 4/30/2012, 61051045 exp 4/30/2012, 61051046 exp 4/30/2012, 61051047 exp 5/31/2012,61051048 exp 5/31/2012, 61051049 exp 5/31/2012, 61051051 exp 5/31/2012, 61051053 exp 5/31/2012, 61051054 exp 5/31/2012, 61051055 exp 5/31/2012, 61051056 exp 5/31/2012, 61055284 exp 5/31/2012, 61055293 exp 5/31/2012, 61055294 exp 5/31/2012, 61055295 exp 5/31/2012, 61055296 exp 5/31/2012, 61057005 exp 5/31/2012, 61057006 exp 5/31/2012, 61057008 exp 6/30/2012, 61057009 exp 6/30/2012, 61057010 exp 6/30/2012, 61059668 exp 6/30/2012, 61059670 exp 6/30/2012, 61059671 exp 6/30/2012, 61059672 exp 6/30/2012, 61059673 exp 6/30/2012, 61060068 exp 6/30/2012, 61060069 exp 6/30/2012, 61060070 exp 6/30/2012, 61060071 exp 6/30/2012, 61060072 exp 6/30/2012, 61060075 exp 7/31/2012, 61060076 exp 7/31/2012, 61060077 exp 7/31/2012, 61060078 exp 7/31/2012, 61062981 exp 7/31/2012, 61062982 exp 7/31/2012, 61062983 exp 7/31/2012, 61062984 exp 7/31/2012, 61062985 exp 7/31/2012, 61062986 exp 7/31/2012, and 61062987 exp 7/31/2012.
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 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 1,111,939 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 MEDICAL, INC.
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