Outlook Pump Set w/150 ml Burette w/15um Filter & Safeline Inj Site, Check Valve, 2 Safeline Inj Sites, 120 in NF3115M
Recall
- Recall Number
- Z-0683-2010
- Event Number
- 53955
- Firm
- B. Braun Medical, Inc.
- FEI Number
- 2523676
- Product Code
- FPA
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 24, 2009
- Posted
- January 26, 2010
- Terminated
- February 14, 2011
- Address
- 901 Marcon Boulevard, Allentown, PA, 18109-9512
Description
Outlook Pump Set w/150 ml Burette w/15um Filter & Safeline Inj Site, Check Valve, 2 Safeline Inj Sites, 120 in NF3115M
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.
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.
The products were shipped to distributors and medical facilities nationwide. The product was also shipped to Afghanistan, Canada and LU.
3660 units