Recalls / —

—#206891

Product

Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY

FDA product code

DYB — Introducer, Catheter

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K211405

Affected lot / code info

Lot # H2817178/ UDI: 00884450770771

Why it was recalled

Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.

Root cause (FDA determination)

Employee error

Action the firm took

On March 18, 2024 Merit Medical issued a "Urgent Medical Device Recall Notice to affected consignees via E-Mail. 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. Please fill out, scan and email the completed Customer Response Form to Customer Service at response@merit.com within 7 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 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.

Recalling firm

Firm

Merit Medical Systems, Inc.

Address

1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern

Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.

Timeline

Recall initiated

2024-03-14

Posted by FDA

2024-05-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #206891. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.