ClearanceBrief
Recall Z-0672-2007 ยท KYG Device, Irrigation, Ocular Surgery

Becton Dickinson and Company

BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618

DateMar 29, 2007 (initiated Mar 2, 2007)
StatusTerminated
ReasonMislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm)
Root causeOther
ActionBD Opthalmic notifiied accounts by telephone on 3/2/07 and followed with letter. Accounts are requested to return product.
Quantity1500 units
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.