Z-2411-2008

Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540...

Name: Z-2411-2008 Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540...
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 Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540. Item/Catalog number 375137. The product is shipped 20 units... 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-2411-2008
Status: Terminated
Initiated: 2008-06-30
Posted: 2008-09-23
Terminated: 2009-05-05
Recalling firm: B Braun Medical Inc
Product: Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540. Item/Catalog number 375137. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk)
Product code: FPA Set, Administration, Intravascular
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: 2340 units
Distribution: Nationwide.
Product codes and lots: Lot number 60999539 exp 3/31/2013

Product code FPA

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)