Date Initiated by Firm | November 24, 2009 |
Date Posted | January 26, 2010 |
Recall Status1 |
Terminated 3 on February 14, 2011 |
Recall Number | Z-0705-2010 |
Recall Event ID |
53955 |
510(K)Number | K954123 |
Product Classification |
Intravascular administration set - Product Code FPA
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Product | Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lock Connector 132 in |
Code Information |
Product Code SS3120. lot numbers 61050615 exp 3/31/2012 and 61053216 exp 4/30/2012. |
Recalling Firm/ Manufacturer |
B. Braun Medical, Inc. 901 Marcon Boulevard Allentown PA 18109-9512
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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 | 5256 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 |
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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.
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510(K) Database | 510(K)s with Product Code = FPA
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