ClearanceBrief
Recall Z-0288-06 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Becton Dickinson Medical Systems

16 G / 5F Dual Lumen L-Cath complete kit with U-Wing

DateDec 15, 2005 (initiated Mar 25, 2005)
StatusTerminated
ReasonAspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
Root causeOther
ActionConsignees were notified via telephone and fax letter, beginning 04/25/2005.
Quantity220 units
DistributionAL, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NJ, OH, OK, PA, TN, TX, WA. No Government or military consignees. Foreign distribution to Australia, Canada, Japan.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K920755L-CATH PEEL AWAY SYSTEM CATHETER
Luther Medical Products, Inc., Jun 7, 1993