ClearanceBrief
Recall Z-0585-04 ยท JXG Shunt, Central Nervous System And Components

Phoenix Biomedical

Cruciform Slit Valve

DateJul 20, 2004 (initiated Jan 6, 2004)
StatusTerminated
Reasonmislabeled - product actually Single Valve
Root causeOther
ActionThe recalling firm faxed copies of recall letters to the hospitals informing them of the problem and the need to return the product.
Quantity5 units
DistributionThe product was shipped to two hospitals - one in CA and one in AZ.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K790126VALVE, H-H CRUCIFORM SLIT
Holter-Hausner Intl., Jan 26, 1979
K853363H-H CRUCIFORM-SLIT VALVE
Holter-Hausner Intl., Sep 3, 1985