Custom Procedure Kit recall: Labeling Error
Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Why was Custom Procedure Kit recalled?
Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
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 # K12T-10167, Lot # K12T-10167, Use By: 2018-11-05
- Product
- Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 24 kits
- Distribution
- U.S.: VA, IL
- Recall date
- October 9, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)