—#87281

Product

Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj sites, 0.2um Filter, Pressure limited check valve 119 in US3169F

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K942988
Affected lot / code info: Product code 352442. Lot numbers: 61031831 exp 2/28/2012, 61031834 exp 3/31/2012, 61047683 exp 4/30/2012, 61047686 exp 5/31/2012, 61057493 exp 6/30/2012, 61057494 exp 6/30/2012, and 61057499 exp 7/31/2012.

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 #87281. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.