Recall Z-1048-2024— Cardinal Health 200, LLC

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 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" URINE DRAINAGE ADD-A-FOLEY TRAY, LUER LOCK SAMPLING PORT, A/R DEVICE, DRAIN SPOUT, PREP TRAY; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD¿ TIP, 16FR (5.3 MM), 5CC; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG (2-person); Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M FOLEY TRAY, COUD¿ TIP, 18FR (6.0 MM), 5CC; Dover" PREMIUM URINE DRAINAGE ADD-A-FOLEY TRAY, LUER-LOCK, DRAIN SPOUT, CATHETER SECUREMENT DEVICE. 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.