Recall Z-1045-2024 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Cardinal Health 200, LLC
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" UNIVERSAL TRAY, 1000 ML BASIN, BZK SWAB STICKS, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover"
| Date | Feb 16, 2024 (initiated Dec 4, 2023) |
| Status | Open, Classified |
| Reason | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| Root cause | Nonconforming Material/Component |
| Action | Cardinal Health Issued an URGENT KIT/TRAY COMPONENT RECALL NOTICE ON 12/04/2023 via FedEx next day delivery. The notice explained the issue, potential risk to health, and requested the following actions be taken: If you locate affected product within your facility, please do the following: 1. QUARANTINE affected kits/trays. 2. ALERT your clinicians of this action. 3. AFFIX the enclosed WARNING LABEL to the front of each kit/tray so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s). 4. NOTE if you have transferred the affected kits |
| Quantity | 17640 units |
| Distribution | US and EMEA, Japan, Latin America |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K903340 | STERILE URETHRAL CATHETER PROCEDURE KITS Superior Healthcare Group, Inc., Oct 4, 1990 |