Recall Z-1043-2024

Cardinal Health 200, LLC · initiated December 4, 2023

Class I Open, Classified

Class I – dangerous or defective products that could cause serious health problems or death

Product

Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, 6 Fr/Ch (2.0 mm); Argyle" Graduated Suction Catheter Tray with Chimney Valve Sterile Saline 8 Fr/Ch (2.67 mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 10 Fr/Ch (3.33 mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, Towel 14 Fr/Ch (4.67 mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 14 Fr/Ch (4.67 mm); Argyle" Graduated Suction Catheter Tray with Chimney Valve Water, 8 Fr/Ch; Argyle" Suction Catheter Tray with Chimney Valve Sterile Water 12 Fr/Ch (4.00 mm); Argyle" Graduated Suction Catheter Tray with Chimney Valve, Water 14 Fr/Ch; Argyle" Suction Catheter Tray with Chimney Valve Sterile Water 10 Fr/Ch (3.33 mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Water, Towel 14 Fr/Ch (4.67 mm)

Codes / lots: a) REF 10082, UDI/DI Lot Numbers: 2216804164, 2219915464 b) REF 12062, Lot Numbers: 2203926164, 2206715364, 2207413264, 2219915564 c) REF 12082, UDI/DI 50192253041673 (cs), 10192253041675 (ea), Lot Numbers: 2201820964, 2205203064 d) REF 12182, UDI/DI 50192253041710 (cs), 10192253041712 (ea); Lot Number: 230381696. Associated Lot Numbers: 2221306664, 2222135264, 2306633164 e) REF 12102, UDI/DI 50192253041680 (cs), 10192253041682 (ea); Lot Numbers: 2200301264, 2201821064, 2215804564, 2206715464, 2210203464, 2303107164 f) REF 12153, Lot Numbers: 2200423964, 2203505264, 2204604164, 2219905464, 2220700264, 2221306564, 2234028964, 2234029064, 2301204364, 2234029764. 2234729464, 2234729564, 2302409864, 2302419564, 2308901764, 2324809964 2135114264 g) REF 12142, UDI/DI 50192253041697 (cs), 10192253041699 (ea); Lot Numbers: 2227022264, 2302419564, 2311517164. Other Lot Numbers:2200423864, 2204604064, 2208105864, 2211605564, 2209404264, 2210203564, 2213010564, 2215804664, 2216804464, 2219905364, 2220700164, 2221306464, 2222116164, 2223502664, 2232603864, 2303831264, 2234017364, 2302419664, 2303816964, 2306633064, 2315904264, 2308902364, 2311517064, 2312110664, 2315904364, 2315904464…

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-1043-2024
Initiated
December 4, 2023
Posted by FDA
February 16, 2024
Product code
JOL – Catheter And Tip, Suction
Quantity
25896 units
Distribution
US and EMEA, Japan, Latin America
Recalling firm
Cardinal Health 200, LLC, Waukegan, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1044-2024 Class ITRACH 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 IDover" 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 IDover 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 IDover" 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 IDover" 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 IDover" 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-1050-2024 Class IDover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 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
Z-1051-2024 Class IDover" 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 IDover" 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