Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction...
FDA Recall #Z-1043-2024 — Class I — December 4, 2023
Product Description
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)
Reason for Recall
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Recalling Firm
Cardinal Health 200, LLC — Waukegan, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
25896 units
Distribution
US and EMEA, Japan, Latin America
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.