Z-0487-03

Ultrakleen KSponge II Spears Catalog #: K20-5012

Name: Z-0487-03 Ultrakleen KSponge II Spears Catalog #: K20-5012
Creator: Ultracell Medical Technologies
Published: 2003-01-08
License: https://open.fda.gov/license/

Ultracell Medical Technologies, Inc. / initiated 2003-01-08 / Terminated / root cause: sterility

FDA source

Ultracell Medical Technologies began a recall of Ultrakleen KSponge II Spears Catalog #: K20-5012 on 2003-01-08. The reason FDA records is "Sterility of the device is compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0487-03
Status: Terminated
Initiated: 2003-01-08
Posted: 2003-01-30
Terminated: 2012-05-01
Recalling firm: Ultracell Medical Technologies, Inc.
Product: Ultrakleen KSponge II Spears Catalog #: K20-5012
Product code: HOZ Sponge, Ophthalmic
Reason for recall: Sterility of the device is compromised
Root cause tag: sterility
FDA root cause: Other
Action: Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts.
Quantity in commerce: 4,047 units
Distribution: Nationwide
Product codes and lots: Lot Number: 063207 Exp. 10/2005

Product code HOZ

K923922Class IISurgical SpearsUltracell Medical Technologies, Inc. / cleared 1993-03-19

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)