Merit Medical Prelude Pro Sheath Introducter recall
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to…
Why was Merit Medical Prelude Pro Sheath Introducter recalled?
Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.
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?
Catalo Number PR0-6F-11-038, Lot Number H767887
- Product
- Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to…
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 1,445
- Distribution
- Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany.
- Recall date
- July 1, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)