Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0897-05

Dr. Fog Endoscopic fog prevention kit

Aspen Surgical Products, Inc. / initiated 2005-05-15 / Terminated / root cause: manufacturing process

Aspen Surgical Products, Inc. began a recall of Dr. Fog Endoscopic fog prevention kit on . The reason FDA records is "An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0897-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Aspen Surgical Products, Inc.
Product
Dr. Fog Endoscopic fog prevention kit.
Product code
KOG
Reason for recall
An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Consignees were notified via phone on 5/15/05. Wholesalers were requested to notify their customers.
Quantity in commerce
2460 packages.
Distribution
Nationwide.
Product codes and lots
Lot 2007-05-25; exp. May 2007.