Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY

FDA device recall Z-1874-2024 · posted 2024-05-20 · Open, Classified

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

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

Action taken

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.

Root cause

Employee error

Status

Open, Classified

Product code

DYB

Quantity affected

18 units

Distribution

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

Date initiated

2024-03-14

Date posted

2024-05-20

Location

South Jordan, UT

Related 510(k) clearances