Recall Z-1052-2024— Cardinal Health 200, LLC

Name: FDA recall Z-1052-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-04

Class I · Ongoing

Class I FDA medical device recall by Cardinal Health 200, LLC, initiated 2023-12-04. It names one FDA 510(k) clearance: K860484. Product: Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE. 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

510(k) clearances named in this recall

1 on FDA's record

K860484 — CURITY & KENGUARD SILICONE COATED FOLEY CATHETERThe Kendal Co.·cleared 1986-03-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE

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.