—#87424

Product

Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pressure Limited Check Valve 134 in

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K904518
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Boulevard, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: The products were shipped to distributors and medical facilities nationwide. The product was also shipped to Afghanistan, Canada and LU.

Timeline

Recall initiated: 2009-11-24
Posted by FDA: 2010-01-26
Terminated: 2011-02-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87424. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.