B. Braun Medical, Inc. Safeline Y Type Blood Set for Outlook Pump w/Safeline Inj Site, 170um Blood Filter, Spin lock Connector 138 in Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Safeline Y Type Blood Set for Outlook Pump w/Safeline Inj Site, 170um Blood Filter, Spin lock Connector 138 in
Brand
B. Braun Medical, Inc.
Lot Codes / Batch Numbers
Product Code NF3120. Lot numbers: 61040779 exp 3/31/2012, 61049780 exp 3/31/2012, 61049782 exp 5/31/2012, 61049783 exp 5/51/2012, and 61062116 exp 7/31/2012.
Products Sold
Product Code NF3120. Lot numbers: 61040779 exp 3/31/2012, 61049780 exp 3/31/2012, 61049782 exp 5/31/2012, 61049783 exp 5/51/2012, and 61062116 exp 7/31/2012.
B. Braun Medical, Inc. is recalling Safeline Y Type Blood Set for Outlook Pump w/Safeline Inj Site, 170um Blood Filter, Spin lock Connec 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