Z-1912-2023Class II

Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only

Name: Z-1912-2023 Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Creator: Merit Medical Systems, Inc.
Published: 2023-04-22
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2023-04-22 / Open, Classified / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only on 2023-04-22. FDA classified it as Class II and gives the reason as "There is a potential that valve assemblies will not open. preventing fluid from draining". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1912-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-22
Posted: 2023-06-14
Recalling firm: Merit Medical Systems, Inc.
Product: Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Product code: PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Reason for recall: There is a potential that valve assemblies will not open. preventing fluid from draining.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Beginning on April 22, 2023, Merit Medical issued an "Urgent Medical Device Recall Notice" to affected consignees via FedEx and UPS. On May 31, 2023, Merit Medical expanded the scope and notified additional consignees. Merit Medical asked consignees to take the following actions: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. For Aspira Valve Replacement Kits, please immediately return all affected product in your possession to Merit, per the instructions in the attached CRF. 5. For Aspira Insertion Trays, follow the attached instructions for placing the recall labels. At the point of use, the valve assembly in the Insertion Tray is to be discarded and replaced by one of the replacement Aspira Valve Repair Kits. 6. Please fill out, scan and email the completed Customer Response Form to Customer Service at [email protected] within seven (7) days. All affected product shipped to you must be accounted for on the CRF. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
Quantity in commerce: 156 units
Distribution: Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.
Product codes and lots: Lot # I2632727, I2558682, I2623159, I2618461 ; UDI-DI: 00884450398173

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1912-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1908-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14
Z-1909-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14
Z-1910-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14
Z-1911-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14
Z-1912-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14
Z-1913-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14
Z-1914-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14
Z-1915-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14
Z-1916-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14
Z-1917-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14
Z-1918-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14
Z-1919-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14
Z-1920-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-14

Product code PNG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)