Class 1 Device Recall Cardinal Health ARGYLE

• Date Initiated by Firm: December 04, 2023
• Date Posted: February 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1043-2024
• Recall Event ID: 93551
• Product Classification: Catheter and tip, suction - Product Code JOL
• 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)
• Code Information: 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, 2326115964, 2324810464, 2324809764 h) REF 10122, Lot Numbers: 2219310964, 2300121064, 2303816764, 2328306664 I) REF 10142, UDI/DI 50192253041642 (cs), 10192253041644 (ea); Lot Numbers: 2324809764. Associated Lot Numbers: 2215804464, 2216520864, 2216804364, 2221306364, 2222116064, 2222802464, 2223502364, 2224236664, 2224921364, 2226313264, 2227022164, 2300121164, 2303107064, 2326115764, 2326115864 j) REF 10102, UDI/DI 50192253041628 (cs), 10192253041620 (ea); Lot Numbers: 2226313264. Associated Lot Numbers: 2216804264, 2219904964, 2234017264, 2302409564 k) REF 12191, 50192253041727 (cs), 10192253041729 (ea): Lot Numbers: 2324810164. Associated Lot Numbers: 2219311064, 2219905564, 2220700364, 2221306764, 2222116264
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 3651 Birchwood Dr; Waukegan IL 60085-8337
• For Additional Information Contact: 847-887-5500
• Manufacturer 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: 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.
• Quantity in Commerce: 25896 units
• Distribution: US and EMEA, Japan, Latin America
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.