Medical DevicesNationwide
Medegen Medical Products, LLC GENT-L-KARE STERILE MID-STREAM URINE COLLECTOR Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GENT-L-KARE STERILE MID-STREAM URINE COLLECTOR
Brand
Medegen Medical Products, LLC
Lot Codes / Batch Numbers
Catalog # 4150, Lot number 037667A2.
Products Sold
Catalog # 4150 , Lot number 037667A2.
Medegen Medical Products, LLC is recalling GENT-L-KARE STERILE MID-STREAM URINE COLLECTOR due to Finished products were not sterilized.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Finished products were not sterilized.
Recommended Action
Per FDA guidance
Medegen has notified all direct accounts by certified mail on 4/30/03.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026