FDA Medical Device Recalls (openFDA)
Medegen Medical Products, LLC: GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE
- Recall number
- Z-0860-03
- Recalling firm
- Medegen Medical Products, LLC
- Product
- GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE
- Status
- Terminated
- Initiated
- 2003-04-30
- Posted
- 2003-05-22
- Terminated
- 2003-11-14
- Reason
- Finished products were not sterilized.
- Root cause
- Other
- Action
- Medegen has notified all direct accounts by certified mail on 4/30/03.
- Quantity
- not on file
- Distribution
- Nationwide domestic distribution. Foreign distribution to Canada and Saudia Arabia. No government and military consignees.
- Lot, serial or model codes
- Catalog # 4173, Lot number 038594A1.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KCP
- Firm FEI
- 1716847
- Firm city
- Northglenn
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28