Z-2243-2021Class II

MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018"...

Name: Z-2243-2021 MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018"...
Creator: Merit Medical Systems, Inc.
Published: 2021-07-21
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2021-07-21 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of 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... on 2021-07-21. FDA classified it as Class II and gives the reason as "There is a potential that a package sheath contains an incorrect dilator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2243-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-21
Posted: 2021-08-12
Terminated: 2023-03-13
Recalling firm: Merit Medical Systems, Inc.
Product: 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
Product code: DYB Introducer, Catheter
Reason for recall: There is a potential that a package sheath contains an incorrect dilator.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Merit Medical issued an "Urgent Medical Device Recall Notice" on July 12, 2021 via FedEx to all affected consignees. In addition to informing consignees about the recall, Merit Medical request consignees 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 recall. 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. Please fill out, scan, and email the completed CRF to Customer Service at [email protected] within 10 business days. All affected product shipped to you must be accounted for on the CRF. 5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF. 6. Adverse events experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch or by phone at 1-800-332-1088. 7. If you have any questions concerning this communication, please dont hesitate to contact your Merit Sales Representative or Merit Customer Service at (801) 208-4381 | Hours: 6 am to 6 pm MDT | Mon-Fri.
Quantity in commerce: 373 UNITS
Distribution: 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.
Product codes and lots: Lot # H2069291

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2243-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2243-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12

Product code DYB

K082063Class IIPrelude Short Sheath IntroducerMerit Medical Systems, Inc. / cleared 2008-10-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)