ClearanceBrief
Recall Z-0818-2007 ยท FPA Set, Administration, Intravascular

B. Braun Medical, Inc.

Ultrasite Horizon Pump IV Set. The product is shipped in cases containing 24 sets.

DateMay 31, 2007 (initiated Apr 18, 2007)
StatusTerminated
ReasonSecondary infusion backs up into primary container.
Root causeOther
ActionThe 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.
Quantity2.5 million for all products
DistributionNationwide and Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K904518VOLUMETRIC INFUSION PUMP
Kendall Mcgaw Laboratories, Inc., Oct 17, 1990
K955585V2 INJECTION SITE
B.Braun Medical, Inc., May 15, 1996