Recall Z-1050-2024
Cardinal Health 200, LLC · initiated December 4, 2023
Class I – dangerous or defective products that could cause serious health problems or death
Product
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
Codes / lots: 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
Reason for recall
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
FDA-determined cause: Nonconforming Material/Component
Action taken
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/trays to other departments or facilities within your system, please provide a copy of this notice and recall acknowledgement form to them. 5. DISTRIBUTOR if you have further distributed affected kits/trays, please notify your customers of this recall. 6. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of over labeled product via email GMB-FieldCorrectiveAction@cardinalhealth.com or fax to 614.652.9648. Additional labels will be sent to your facility upon request. For field action concerns, please contact the field action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332. On 12/21/2023, Cardinal Health issued an URGENT: EXPANSION KIT/TRAY COMPONENT RECALL notice stating the following: As an update to Cardinal Healths initial communication on December 05, 2023, additional kit/trays are being included as part of the component recall. If you did not receive the initial communication on December 05, 2023, you were not impacted by the initial scope of the event. Instructions below are unchanged. Please reference Attachment 1 - Updated Impacted Products V2 for additional products impacted. The notice explained the issue, potential risk to health, and requested the same actions be taken as listed above in the 12/04/2023 letter.
Details
- Recall number
- Z-1050-2024
- Initiated
- December 4, 2023
- Posted by FDA
- February 16, 2024
- Product code
- EZL – Catheter, Retention Type, Balloon
- Quantity
- 4620 units
- Distribution
- US and EMEA, Japan, Latin America
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1043-2024 Class I | Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm)…Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse… | 12/04/2023Open, Classified |
| Z-1044-2024 Class I | TRACH KIT W/HYDROGEN & SALIConvenience kits were manufactured and distributed with components which were subsequently recalled by Nurse… | 12/04/2023Open, Classified |
| Z-1045-2024 Class I | Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML…Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse… | 12/04/2023Open, Classified |
| Z-1046-2024 Class I | Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY…Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse… | 12/04/2023Open, Classified |
| Z-1047-2024 Class I | Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML…Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse… | 12/04/2023Open, Classified |
| Z-1048-2024 Class I | Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD TIP, 16 FR (5.3 MM), 5 CC, 2000 ML…Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse… | 12/04/2023Open, Classified |
| Z-1049-2024 Class I | Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR…Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse… | 12/04/2023Open, Classified |
| Z-1051-2024 Class I | Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML…Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse… | 12/04/2023Open, Classified |
| Z-1052-2024 Class I | Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG…Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse… | 12/04/2023Open, Classified |