Z-0828-03

Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains...

Name: Z-0828-03 Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains...
Creator: Aspen Surgical Products, Inc.
Published: 2003-04-30
License: https://open.fda.gov/license/

Aspen Surgical Products, Inc. / initiated 2003-04-30 / Terminated / root cause: packaging

FDA source

Aspen Surgical Products, Inc. began a recall of Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge on 2003-04-30. The reason FDA records is "Sterility compromised - incomplete sterile package seal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0828-03
Status: Terminated
Initiated: 2003-04-30
Posted: 2003-05-15
Terminated: 2003-11-13
Recalling firm: Aspen Surgical Products, Inc.
Product: Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Sterility compromised - incomplete sterile package seal.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm called each customer on 4/30/03 and requested that the product be returned. Distributors were asked to notify their customers of the recall.
Quantity in commerce: 299 boxes
Distribution: Nationwide, Japan and United Kingdom.
Product codes and lots: Lot 2005-02-17. Exp. February 2005.

Product code GCJ

K932449Class IIDr. FogO.R. Concepts, Inc. / cleared 1993-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)