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Terminated

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.

FDA Recall Z-2407-2008 · Posted 2008-09-23

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2008-06-30
Date Terminated2009-05-05
Product Quantity13,360 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. · 1992-07-30K904518VOLUMETRIC INFUSION PUMPKendall Mcgaw Laboratories, Inc. · 1990-10-17

Official Source

View FDA Recall →

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

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