ClearanceBrief
Recall Z-0897-05 ยท KOG

Aspen Surgical Products, Inc.

Dr. Fog Endoscopic fog prevention kit.

DateJun 16, 2005 (initiated May 15, 2005)
StatusTerminated
ReasonAn improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date.
Root causeProcess control
ActionConsignees were notified via phone on 5/15/05. Wholesalers were requested to notify their customers.
Quantity2460 packages.
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K932449DR. FOG
O.R. Concepts, Inc., Aug 11, 1993