ClearanceBrief
Recall Z-0366-06 ยท HCA Catheter, Ventricular

Vygon Neuro

7 cm Catheter Reservoir with 10 cm extension

DateJan 10, 2006 (initiated Mar 24, 2005)
StatusTerminated
Reasonstylet in package is shorter than that claimed on the label
Root causeOther
ActionThe recalling firm issued a letter to their customers informing them of the problem and the need to return the product.
Quantity11 units
DistributionThe product was shipped to a hospital in CA and a distributor in Germany.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K853361H-H VENTRICULAR CATHETERS & RESERVOIRS
Holter-Hausner Intl., Aug 28, 1985
K853362H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER
Holter-Hausner Intl., Sep 3, 1985