Recall Z-1050-2024 ยท EZL Catheter, Retention Type, Balloon
Cardinal Health 200, LLC
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"
| 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 | 4620 units |
| Distribution | US and EMEA, Japan, Latin America |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024010 | DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER The Kendall Company Div. of Tyco Healthcare Group, Jun 11, 2003 |
| K780062 | CATHETER/HEMOSTATIC/GERIATRIC Kendall Research Center, Feb 14, 1978 |
| K990500 | KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C The Kendal Co., Sep 28, 1999 |