CLASS II ONGOING Device recall · Reported 21 Jun 2023 · FDA Enforcement Report
Aspira Pleural Drainage Catheter Insertion Tray 5F recalled
Merit Medical Systems is recalling Aspira Pleural Drainage Catheter Insertion Tray 5F, distributed nationwide in the US. The recall was initiated on 22 Apr 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1912-2023
- FDA event ID
- 92301
- Recalling firm
- Merit Medical Systems, South Jordan, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Apr 2023
- FDA classified
- 14 Jun 2023
- Reported
- 21 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 22 Apr 2023 | Recall initiated by company | |
| 14 Jun 2023 | Classified by FDA | +53 days |
| 21 Jun 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential that valve assemblies will not open. preventing fluid from draining.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is Aspira Pleural Drainage Catheter Insertion Tray 5F recalled?
Yes. Merit Medical Systems recalled Aspira Pleural Drainage Catheter Insertion Tray 5F on 22 Apr 2023. The recall is Class II and its status is Ongoing. Recall number Z-1912-2023.
Why was it recalled?
There is a potential that valve assemblies will not open. preventing fluid from draining.
Which lots are affected?
Lot # I2632727, I2558682, I2623159, I2618461 ; UDI-DI: 00884450398173
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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