Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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)

FDA Recall Z-2411-2008 · Posted 2008-09-23

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2008-06-30
Date Terminated2009-05-05
Product Quantity2340 units

Reason for Recall

incorrect burette was packaged with the product

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955585V2 INJECTION SITEB.Braun Medical, Inc. · 1996-05-15K921860MODIFICATION TO IV SPIKEMcgaw, Inc. · 1992-07-30K781744IV SET WITH GRADUATED CHAMBERNational Patent Development Corp. · 1978-12-07

Official Source

View FDA Recall →

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

↑