FDA-Device2024-02-28Class I

Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD

Cardinal Health 200, LLC
Hazard

Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

Sold states
US and EMEA, Japan, Latin America
Affected count
36300 units
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1051-2024

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