ClearanceBrief
Recall Z-2408-2008 ยท FRN Pump, Infusion

B. Braun Medical, Inc.

Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System.

DateSep 23, 2008 (initiated Jun 30, 2008)
StatusTerminated
Reasonincorrect burette was packaged with the product
Root causeMixed-up of materials/components
ActionThe 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.
Quantity280 units
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K904518VOLUMETRIC INFUSION PUMP
Kendall Mcgaw Laboratories, Inc., Oct 17, 1990
K921860MODIFICATION TO IV SPIKE
Mcgaw, Inc., Jul 30, 1992
K942988FILTERED EXTENSION SETS
B. Braun of America, Inc., Jul 14, 1995