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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Merit Medical Systems, Inc.: There is a potential that valve assemblies will not open. preventing fluid from draining.

Agency Publication Date: June 14, 2023
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Affected Products

Product: Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only

Lot # I2614171, I2559314, I2546596, I2614170, I2538442, I2564679, I2548181, I2623231; UDI-DI: 00884450394946

Lot Numbers:
I2614171
Product: Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only

Lot # I2604364, I2604393, I2587036, I2564649, I2558681, I2604394, I2609065, I2623156, I2577984; UDI-DI: 00884450394960

Lot Numbers:
I2604364
Product: Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only

Lot # I2587050; UDI-DI: 00884450488447

Lot Numbers:
I2587050
Product: Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only

Lot # I2578012; UDI-DI: 00884450488539

Lot Numbers:
I2578012
Product: Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only

Lot # I2587055; UDI-DI: 00884450488416

Lot Numbers:
I2587055
Product: Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only

Lot # I2559306; UDI-DI: 00884450488492

Lot Numbers:
I2559306
Product: Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only

Lot # I2605742; UDI-DI: 00884450398166

Lot Numbers:
I2605742
Product: Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only

Lot # I2605742; UDI-DI: 00884450398166

Lot Numbers:
I2605742
Product: Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only

Lot # I2538438, I2614180, I2623234/ UDI: 00884450394892

Lot Numbers:
I2538438
Product: Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only

Lot # I2533611, I2546597, I2559292, I2548163 & I2578001; UDI-DI: 00884450394908

Lot Numbers:
I2533611
Product: Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only

Lot # I2632727, I2558682, I2623159, I2618461 ; UDI-DI: 00884450398173

Lot Numbers:
I2632727
Product: Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only

Lot # I2548172, I2568218, I2553914, I2614174, I2638785, I2559299; UDI-DI: 00884450394915

Lot Numbers:
I2548172
Product: Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only

Lot # I2559297, I2564678, I2553915, I2614173, I2568219; UDI-DI: 00884450394939

Lot Numbers:
I2559297

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92301
Status: Active
Manufacturer: Merit Medical Systems, Inc.
Manufactured In: United States
Units Affected: 13 products (5 units; 27 units; 175 units; 670 units; 156 units; 524 units; 436 units; 1054 units; 2559 units; 17 units; 7 units; 40 units; 2 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.