ClearanceBrief
Recall Z-0635-05 ยท DQO Catheter, Intravascular, Diagnostic

Millar Instruments, Inc

Mikro-Tip Disposable Angiographic Catheter manufactured by Millar Instruments, Houston, Texas

DateMar 18, 2005 (initiated Jan 14, 2005)
StatusTerminated
ReasonWire braiding protruding from the catheter.
Root causeOther
ActionThe firm initiated the recall via e-mail to direct accounts on 01/14/2005 and letter on 01/20/2005.
Quantity28 catheters
DistributionProduct was distributed to distributors and hospitals in MN, CA, and NY.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K993694MIKRO-TIP ANGIOGRAPHIC CATHETER
Millar Instruments, Inc., Mar 1, 2000