Prelude IDEAL 4 F Hydrophilic Sheath Introducer recall
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Why was Prelude IDEAL 4 F Hydrophilic Sheath Introducer recalled?
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
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?
UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24
- Product
- Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 40
- Distribution
- International distribution to the country of Japan.
- Recall date
- April 2, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)