ClearanceBrief
Recall Z-2412-2008 ยท FPA Set, Administration, Intravascular

B. Braun Medical, Inc.

Add-On Burette Set with 150 ml burette and Ultrasite Injection Site without automatic shutoff. Item/Catalog number 375111. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk)

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.
Quantity2560 units
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K781744IV SET WITH GRADUATED CHAMBER
National Patent Development Corp., Dec 7, 1978
K790062IV ADMINISTRATION SET WITH BACKCHECK
National Patent Development Corp., Apr 10, 1979
K955585V2 INJECTION SITE
B.Braun Medical, Inc., May 15, 1996