CLASS II Device recall · Reported 18 Aug 2021 · FDA Enforcement Report

Meritmedical Prelude Short Sheath Introducer recalled

Merit Medical Systems is recalling Meritmedical Prelude Short Sheath Introducer, distributed nationwide in the US. The recall was initiated on 21 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # H2069291

Quantity recalled373 UNITS

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-2243-2021
FDA event ID: 88352
Recalling firm: Merit Medical Systems, South Jordan, UT
Classification: Class II
Status: Terminated
Recall initiated: 21 Jul 2021
FDA classified: 12 Aug 2021
Reported: 18 Aug 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

21 Jul 2021	Recall initiated by company
12 Aug 2021	Classified by FDA	+22 days
18 Aug 2021	Published in enforcement report	+6 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 a package sheath contains an incorrect dilator.

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

MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of ID, HI, TX, CA, AZ, MN, UT, KS, MO and the countries of Republic of Korea, Netherlands, Germany, Cyprus, Italy, Sweden, Taiwan, and Spain.

Nationwide Arizona California Hawaii Kansas Minnesota Missouri Texas Utah

Questions about this recall

Is Meritmedical Prelude Short Sheath Introducer recalled?

Yes. Merit Medical Systems recalled Meritmedical Prelude Short Sheath Introducer on 21 Jul 2021. The recall is Class II and its status is Terminated. Recall number Z-2243-2021.

Why was it recalled?

There is a potential that a package sheath contains an incorrect dilator.

Which lots are affected?

Lot # H2069291

Where was it sold?

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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