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FDAFDA · Food and drugs·Recall number Z-1043-2024

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)

Published February 28, 2024 · Recall initiated: December 4, 2023

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Cardinal Health 200, LLC
Distributor
US and EMEA, Japan, Latin America
Lot
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
Risk classification
Class I
Area (FDA)
device
Country
United States

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