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U.S. Department of Health and Human Services

Class 2 Device Recall Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lock Connect

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 Class 2 Device Recall Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lock Connectsee related information
Date Initiated by FirmNovember 24, 2009
Date PostedJanuary 26, 2010
Recall Status1 Terminated 3 on February 14, 2011
Recall NumberZ-0707-2010
Recall Event ID 53955
510(K)NumberK955585 
Product Classification Intravascular administration set - Product Code FPA
ProductSafesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lock Connector 132 in
Code Information Product Code US3120. Lot numbers:61044311 exp 2/28/2012, 61044313 exp 2/28/2012, 61047621 exp 3/31/2012, 61047623 exp 3/31/2012, 61049811 exp 3/31/2012, 61049812 exp 3/31/2012, 61049813 exp 3/31/2012, 61049815 exp 3/31/2012, 61049816 exp 4/30/2012, 61019817 exp 4/30/2012, 61051105 exp 4/30/2012, 61052697 exp 5/31/2012, 61057011 exp 5/31/2012, 61057012 exp 5/31/2012, 61057014 exp 5/31/2012, 61057256 exp 6/30/2012, 61061750 exp 6/30/2012, 61061751 exp 6/30/2012, 61061752 exp 7/31/2012, and 61061753 exp 7/31/2012.
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown PA 18109-9512
For Additional Information ContactScott 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
ActionThe 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 Commerce289049 units
DistributionThe products were shipped to distributors and medical facilities nationwide. The product was also shipped to Afghanistan, Canada and LU.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FPA
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