—#188474

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

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K082063
Affected lot / code info: Lot # H2069291

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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 response@merit.com 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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-07-21
Terminated: 2023-03-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188474. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.