Z-0763-03

Craniotomy Pack

Name: Z-0763-03 Craniotomy Pack
Creator: Windstone Medical, Inc.
Published: 2003-03-25
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2003-03-25 / Terminated / root cause: packaging

FDA source

Windstone Medical, Inc. began a recall of CRANIOTOMY PACK on 2003-03-25. The reason FDA records is "Product has latex free symbol on package, yet contains latex components". 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-0763-03
Status: Terminated
Initiated: 2003-03-25
Posted: 2003-04-22
Terminated: 2003-09-09
Recalling firm: Windstone Medical Packaging, Inc.
Product: Craniotomy Pack
Reason for recall: Product has latex free symbol on package, yet contains latex components.
Root cause tag: packaging
FDA root cause: Other
Action: On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm.
Quantity in commerce: 123
Distribution: The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
Product codes and lots: Catalog number CPA-2382 Lot numbers 000000344, 000000612, 000001469, 000002199, 000003462, 000003952, 000004570, 000005078, 000005597, 000005879, 000005852, 000006499, 000006505

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)