Z-0860-03

GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE

Name: Z-0860-03 GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE
Creator: Medegen Medical Products, LLC
Published: 2003-04-30
License: https://open.fda.gov/license/

Medegen Medical Products / initiated 2003-04-30 / Terminated / root cause: sterility

FDA source

Medegen Medical Products, LLC began a recall of GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE on 2003-04-30. The reason FDA records is "Finished products were not sterilized". 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-0860-03
Status: Terminated
Initiated: 2003-04-30
Posted: 2003-05-22
Terminated: 2003-11-14
Recalling firm: Medegen Medical Products
Product: GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE
Product code: KCP Syringe, Ent
Reason for recall: Finished products were not sterilized.
Root cause tag: sterility
FDA root cause: Other
Action: Medegen has notified all direct accounts by certified mail on 4/30/03.
Distribution: Nationwide domestic distribution. Foreign distribution to Canada and Saudia Arabia. No government and military consignees.
Product codes and lots: Catalog # 4173, Lot number 038594A1.

Product code KCP

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)