FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
- Recall number
- Z-1875-2024
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
- Status
- Open, Classified
- Initiated
- 2024-03-14
- Posted
- 2024-05-20
- Terminated
- not on file
- Reason
- Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 27 units
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.
- Lot, serial or model codes
- Lot # H2817178/ UDI: 00884450770771
- 510(k) numbers
- ["K211405"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28