FDA-Device2022-12-14Class II
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the bladder of a patient.
Cardinal Health
Hazard
Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
Sold states
Nationwide
Affected count
N/A
Manufactured in
777 West St, N/A, Mansfield, MA, United States
Products
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the bladder of a patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0361-2023Don't want to check this manually?
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