Cardinal Health 200, LLC: Medical Device Recall in 2024 - (Recall #: Z-1050-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2-WAY; Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY INSERTION TRAY, 5 CC, PREP TRAY, 16 FR (5.3 MM); Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 16 FR (5.3 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 18 FR (6.0 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover" HYDROGEL COATED COUD¿ TIP LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER-LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED COUD¿ TIP LATEX 400 ML U/M FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML BAG

Product Classification:

Class I

Date Initiated: December 4, 2023

Date Posted: February 28, 2024

Recall Number: Z-1050-2024

Event ID: 93551

Reason for Recall:

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

Status: Ongoing

Product Quantity: 4620 units

Code Information:

a) 6146LL, UDI/DI 30884521015504 (cs), 10884521015500 (ea), Lot Numbers: 2222830564, 2234606164, 2300129064, 2300129264, 2206723564, 2206723664, 2213047764, 2213741964, 2214452664, 2216503164, 2211628464, 2225100964, 2305403264, 2207404564, 2203933464, 2209525664, 2210210364, 2210210464, 2212323064, 2215116164 b) P4P16CSD, UDI/DI 20884521143347 (cs), 10884521143340 (ea), Lot Numbers: 2231220064, 2303011264, 2309041164, 2312914064, 2319901964, 2310300564, 2322102864, 2207803464, 2212321564 c) 7006ICLL, Lot Numbers: 2215120464, 2223120264 d) 7006LL, Lot Numbers: 2207805664, 2208817564, 2212323864, 2215826764, 2223542964, 2223543064, 2231912364, 2232102364, 2206721364, 2206721464, 2210904064, 2209525964, 2213048664, 2232601264

Distribution Pattern:

US and EMEA, Japan, Latin America

Voluntary or Mandated:

Voluntary: Firm initiated