ClearanceBrief
Recall Z-1344-04 ยท HNN Knife, Ophthalmic

BD Opthalmic Systems

BD EdgeAhead Stiletto/MVR Knife 1.1mm (19g) REF 585240

DateAug 14, 2004 (initiated Sep 16, 2004)
StatusTerminated
ReasonBlade may become detached from the handle
Root causeOther
ActionBD Medical initiated recall by telephone the week of 7/19/04 to direct accounts advising of the recall action, requesting return and providing replacement product.
Quantity6945 units
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K820618MICROSURGERY KNIFE
Visitec Co., Apr 9, 1982