FDA-Device2018-04-04Class II
8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
Medical Components, Inc dba MedComp
Hazard
The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
Sold states
CA, AR. AL
Affected count
24 Eaches
Manufactured in
1499 Delp Dr, Harleysville, PA, United States
Products
8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1271-2018Don't want to check this manually?
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