Z-2407-2008

Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120...

Name: Z-2407-2008 Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120...
Creator: B. Braun Medical, Inc.
Published: 2008-06-30
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2008-06-30 / Terminated / root cause: packaging

FDA source

B. Braun Medical, Inc. began a recall of Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is... on 2008-06-30. The reason FDA records is "incorrect burette was packaged with the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2407-2008
Status: Terminated
Initiated: 2008-06-30
Posted: 2008-09-23
Terminated: 2009-05-05
Recalling firm: B Braun Medical Inc
Product: Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System.
Product code: FRN Pump, Infusion
Reason for recall: incorrect burette was packaged with the product
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: The firm issued a Product Removal Notice dated 6/20/08 via USPS Certified Mail with registered receipt mail to all customers in receipt of affected product. The notice informs customers of the problem, to cease use and distribution immediately, and to return the product. Contact B. Braun Medical at 1-800-227-2862 for assistance.
Quantity in commerce: 13,360 units
Distribution: Nationwide.
Product codes and lots: Lot numbers 60999552 exp 4/30/2011, 00VL986720 exp 1/31/2013, 00VL986732 exp 1/31/2013, and 60999551 exp 3/31/2013.

Product code FRN

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)