510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-0703-2010

Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pressure Limited Check Valve...

B Braun Medical Inc / initiated 2009-11-24 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

B. Braun Medical, Inc. began a recall of Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pressure Limited Check Valve 134 in on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0703-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
B Braun Medical Inc
Product
Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pressure Limited Check Valve 134 in
Product code
FPA Set, Administration, Intravascular
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.
Root cause tag
manufacturing process
FDA root 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.
Product codes and lots
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.