Z-0679-2010

Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, 2 Ultrasite Inj Sites, Check Valve 120...

Name: Z-0679-2010 Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, 2 Ultrasite Inj Sites, Check Valve 120...
Creator: B. Braun Medical, Inc.
Published: 2009-11-24
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2009-11-24 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M on 2009-11-24. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0679-2010
Status: Terminated
Initiated: 2009-11-24
Posted: 2010-01-26
Terminated: 2011-02-14
Recalling firm: B Braun Medical Inc
Product: Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 19420 units
Distribution: The products were shipped to distributors and medical facilities nationwide. The product was also shipped to Afghanistan, Canada and LU.
Product codes and lots: Product Code 375038. Lot numbers: 61030733 exp3/31/2012, 61030734 exp 4/30/2012, 61047279 exp 4/30/2012, and 61053708 exp 5/31/2012.

Product code FPA

K904518Class IIVolumetric Infusion PumpKendall Mcgaw Laboratories, Inc. / cleared 1990-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)