Argyle” Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch
Medical device recall Z-1043-2024. Published in FDA’s Enforcement Report on Feb 28, 2024.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 28, 2024. Copied from openFDA on Oct 27, 2026.
- Class I FDA’s most serious class (needs attention)
- Completed its status, in FDA’s file
- Not named no state, in where it went
- 25896 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
FDA, Device recall enforcement reports. Released Oct 27, 2026. Updated weekly.
Which ones are recalled?
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)
25896 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 27, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,915 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US and EMEA, Japan, Latin America
These words name no state.
FDA, Device recall enforcement reports. Released Oct 27, 2026. Updated weekly.
Is it still going on?
Completed, in FDA’s file.
“The recall action reaches the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.”
openFDA, on “Completed”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 4, 2023.
- FDA classified it on Feb 16, 2024.
- FDA’s Enforcement Report published it on Feb 28, 2024.
FDA, Device recall enforcement reports. Released Oct 27, 2026. Updated weekly.
Who is recalling it?
- Cardinal Health 200, LLC, of Waukegan, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 27, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 27, 2026 and checked Oct 27, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 27, 2026.