Merit Medical Systems, Inc. 2024-05-29 Health serious FDA
Health · FDA · Recall #FDA-Z-1874-2024
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX… Recall
Issued May 29, 2024 · Merit Medical Systems, Inc.
In May 2024, Merit Medical Systems, Inc. recalled the Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
What you should do
- 1 Stop using Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Merit Medical Systems, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Merit Medical Systems, Inc.
- Category
- Health
- Recall date
- May 29, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.
- Recall number
- FDA-Z-1874-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Merit Medical Systems, Inc. has 11 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.