Z-0029-04

Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers...

Name: Z-0029-04 Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers...
Creator: Dow Corning Corp.
Published: 2003-09-05
License: https://open.fda.gov/license/

Dow Corning Corp. / initiated 2003-09-05 / Terminated / root cause: manufacturing process

FDA source

Dow Corning Corp. began a recall of Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes) on 2003-09-05. The reason FDA records is "May be contaminated with iron, chromium and nickel from stainless steel equipment failure during manufacture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0029-04
Status: Terminated
Initiated: 2003-09-05
Posted: 2003-10-15
Terminated: 2004-02-11
Recalling firm: Dow Corning Corp.
Product: Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).
Reason for recall: May be contaminated with iron, chromium and nickel from stainless steel equipment failure during manufacture.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Customers were notified via phone call and by letter dated September 5, 2003. Customer were asked to return unused materials.
Quantity in commerce: 2300
Distribution: United States.
Product codes and lots: material number 3242901; lots 0001531727, 001583486 and 0001671243. material number 3242897; lot 0001604743.

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)