—#72711

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K904518, K921860, K955585
Affected lot / code info: Lot numbers 60999552 exp 4/30/2011, 00VL986720 exp 1/31/2013, 00VL986732 exp 1/31/2013, and 60999551 exp 3/31/2013.

Why it was recalled

incorrect burette was packaged with the product

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Boulevard, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2008-06-30
Posted by FDA: 2008-09-23
Terminated: 2009-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72711. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.