Argyle Suction Catheter Trays with Chimney Valve recalled for defective components
Cardinal Health is recalling multiple Argyle Suction Catheter Tray models due to defective components. The kits containing these recalled components were distributed in the US, Europe, Japan, and Latin America.
The agency’s classification
FDA (Devices): Class I
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation for medical device recall mandates minimum Severe severity per the rubric. No reported deaths or serious injuries are documented, precluding Critical classification.
Plain-English summary
Cardinal Health 200, LLC is recalling various Argyle Suction Catheter Trays with Chimney Valve. The convenience kits were manufactured and distributed containing components that were subsequently recalled by Nurse Assist. Multiple product models with different sizes and configurations are affected, totaling 25,896 units.
The affected products were distributed throughout the United States, Europe, the Middle East, Africa, Japan, and Latin America. Specific product models, lot numbers, and UDI/DI codes are detailed in the official FDA recall notice and manufacturer communications.
Consumers and healthcare facilities with potentially affected units should contact Cardinal Health for additional information and guidance on product return or disposal.
The recalled product
- 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…
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 25,896
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 10 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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