Custom Sheath Introducer Kit recall: Labeling Error
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various…
Why was Custom Sheath Introducer Kit recalled?
labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.
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?
Catalog Number: K21-00031, Lot Number: H1583914, UDI: 00884450426357
- Product
- Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various…
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 15 kits
- Distribution
- US Nationwide distribution in the state of MI.
- Recall date
- May 20, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)