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Terminated

Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lock Connector 132 in

FDA Recall Z-0705-2010 · Posted 2010-01-26

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2009-11-24
Date Terminated2011-02-14
Product Quantity5256 units

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.

Firm Action

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

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K954123LOW PROFILE SAFSITE Y-SITEB.Braun Medical, Inc. · 1995-11-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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