Recall Z-1051-2024— Cardinal Health 200, LLC
Class I · Ongoing
Class I FDA medical device recall by Cardinal Health 200, LLC, initiated 2023-12-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD. Reason: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-12-04
- Firm location
- Waukegan, IL, United States
Product description
Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
Reason for recall
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Data sourced from openFDA. This site is unofficial and independent of the FDA.