Outlook Pump IV Set w/Universal Spike, Check Valve, 3 Safeline Inj Sites, B/C Valve, 3 N/C Valves Stopcock, 118 in NF150

FDA device recall Z-0695-2010 · posted 2010-01-26 · Terminated

Recall details

Recalling firm

B. Braun Medical, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FPA

Quantity affected

672 units

Distribution

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

Date initiated

2009-11-24

Date posted

2010-01-26

Date terminated

2011-02-14

Location

Allentown, PA

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