7F Prelude¿ Short Sheath Introducer recall
7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath…
Why was 7F Prelude¿ Short Sheath Introducer recalled?
Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short Sheath Introducers because the sheath marker tips may detach during use.
What should I do if I have this product?
Review the official FDA enforcement record for current 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 Numbers: H1041469, H1041473, H1036880, H1041464.
- Product
- 7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath…
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 1,265 total
- Distribution
- Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
- Recall date
- April 5, 2017
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)