EXCELSIOR ZR® FLUSH
Received Feb 2, 2026 · Event occurred Jan 5, 2026
Report 2027791-2026-00002 · MDR key 24242041
Device
Generic name
Syringe, 10ml Saline In 10ml
Manufacturer
Excelsior Medical, LlcCatalog number
EMZE010001
Lot number
3145749
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT A DEVICE WAS FOUND TO BE CONTAMINATED WITH MOLD. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN (B)(4) ON (B)(6) 2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT A DEVICE WAS FOUND TO BE CONTAMINATED WITH MOLD.