B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, B/C Valve and Pressure Limited Check Valve, 124 in US1502HP Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, B/C Valve and Pressure Limited Check Valve, 124 in US1502HP
Brand
B. Braun Medical, Inc.
Lot Codes / Batch Numbers
Product Code 470018. Lot numbers: 61048470 exp 2/28/2012, 61048471 exp 3/31/2012, 61048472 exp 4/30/2012
Products Sold
Product Code 470018. Lot numbers: 61048470 exp 2/28/2012, 61048471 exp 3/31/2012, 61048472 exp 4/30/2012
B. Braun Medical, Inc. is recalling Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, B/C Valve and Pressure Limited Check Valv due to System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patien. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026