Cardinal Health 200, LLC: Medical Device Recall in 2024 - (Recall #: Z-1048-2024)

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 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

Product Classification:

Class I

Date Initiated: December 4, 2023

Date Posted: February 28, 2024

Recall Number: Z-1048-2024

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: 195600 units

Code Information:

a) P4P16CSDK, UDI/DI 20884521174068 (cs), 10884521174061 (ea), Lot Numbers: 2134218264, 2231213064, 2231213164, 2231901164, 2231901264, 2303822464, 2303007064, 2307110664, 2310808164, 2315609464, 2319100364, 2319213064, 2203300964, 2210218464, 2211031564, 2213045564, 2214449364, 2215824164, 2216500464, 2217920064, 2219400664, 2300202064, 2304400364, 2304400464, 2301703364, 2303006964, 2308700564, 2309041264, 2312206464, 2321324164, 2322006864, 2211626864, 2305206264, 2322102764, 2206726164, 2216805064, 2313615064, 2313614964, 2312908364, 2309041264, 2201151164, 2201201664, 2202401464, 2200603564, 2205315264, 2209524264, 2213738964, 2215117864; b) P4P18CSDK, UDI/DI 20884521174075 (cs), 10884521174078(ea), Lot Numbers: 2231213564, 2308004464, 2319100564, 2215824364, 2232517864, 2312206964, 2134218564, 2203931664

Distribution Pattern:

US and EMEA, Japan, Latin America

Voluntary or Mandated:

Voluntary: Firm initiated