Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2410-2008

Metriset Burette Set w/Horizon Pump, Ultrasites, 120 in. Item/Catalog number 375150. The product is shipped...

B Braun Medical Inc / initiated 2008-06-30 / Terminated / root cause: packaging

B. Braun Medical, Inc. began a recall of Metriset Burette Set w/Horizon Pump, Ultrasites, 120 in. Item/Catalog number 375150. The product is shipped 20 units per carton. The product is used with the... on . The reason FDA records is "incorrect burette was packaged with the product". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-2410-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
B Braun Medical Inc
Product
Metriset Burette Set w/Horizon Pump, Ultrasites, 120 in. Item/Catalog number 375150. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System.
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
4500 units
Distribution
Nationwide.
Product codes and lots
Lot number 60998893 exp 3/31/2011