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Dr. Fog Endoscopic fog prevention kit recallZ-0897-05 · Aspen Surgical Products, Inc. · initiated May 15, 2005

Terminated All recalls posted in June 2005

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Aspen Surgical Products, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date.

FDA root cause category: Process control

What the company is doing

Consignees were notified via phone on 5/15/05. Wholesalers were requested to notify their customers.

Recall details

Recall number
Z-0897-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 15, 2005
Posted by the FDA
Jun 16, 2005
Recalling firm
Aspen Surgical Products, Inc.
Quantity
2460 packages.
Product code
KOG
FDA submissions
K932449
Distribution
Nationwide.

Product description

Dr. Fog Endoscopic fog prevention kit.

Code information (models, lots, serial numbers)

Lot 2007-05-25; exp. May 2007.

Other devices under the same FDA submission

3 devices cleared under K932449 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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