Prelude Guide Sheath Roadster recall
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Why was Prelude Guide Sheath Roadster recalled?
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # H2800643/ UDI: 00884450770757
- Product
- Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 18 units
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the countries of New Zealand and Canada.
- Recall date
- May 29, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)