Recalls / —

—#51962

Product

Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets.

FDA product code

FPA — Set, Administration, Intravascular

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K904518, K955585

Affected lot / code info

Lot numbers: 60888186 exp 9/11 and 60869008 exp 6/11

Why it was recalled

Secondary infusion backs up into primary container.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued Product Removal Notices on 4/20/07 via certified priority mail. The notice informed the customer of the problem and the need to return the product.

Recalling firm

Firm

B. Braun Medical, Inc.

Address

901 Marcon Boulevard, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern

Nationwide and Canada.

Timeline

Recall initiated

2007-04-18

Posted by FDA

2007-05-31

Terminated

2008-04-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #51962. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.