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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
