ClearanceBrief
Recall Z-1092-04 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Braun,B Medical Inc

Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot numbers: Catalog Number 4253540 - Lot number 3G26258U02 Catalog Number 4253540 - Lot number 3G27258U02

DateJul 20, 2004 (initiated Mar 19, 2004)
StatusTerminated
ReasonMislabeled product. The recalling firm received a complaint that a box of Introcan Safety Catheters, (22G x 1 inch) contained mixed 18G catheters with the same lot number.
Root causeOther
ActionThe recalling firm received a product complaint of a mixed 18G Catheters with 22G Catheters.
Quantity86 units
DistributionThe affected recalling units were distributed nationwide to the following states: AZ, CA, GA, IL, IN, MD, OH, OK, OR, MA, MI, NC, NJ, NY, OR, PA, TX, UT, VA, WI
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K020785INTROCAN SAFETY IV CATHETER
B.Braun Medical, Inc., Aug 28, 2002
K982805INTROCAN SAFETY IV CATHETER
B.Braun Medical, Inc., Jan 14, 1999