Atlas FDA

Dr. Fog Endoscopic fog prevention kit.

FDA device recall Z-0897-05 · posted 2005-06-16 · Terminated

Recall details

Recalling firm
Aspen Surgical Products, Inc.
Reason for recall
An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date.
Action taken
Consignees were notified via phone on 5/15/05. Wholesalers were requested to notify their customers.
Root cause
Process control
Status
Terminated
Product code
KOG
Quantity affected
2460 packages.
Distribution
Nationwide.
Date initiated
2005-05-15
Date posted
2005-06-16
Date terminated
2005-09-16
Location
Byron Center, MI

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Related 510(k) clearances

RecordFirmDate
DR. FOG (K932449)O.R. Concepts, Inc.1993-08-11