Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Reported: October 9, 2019 Initiated: October 26, 2018 #Z-0027-2020
Product Description
Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Reason for Recall
Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 24 kits
- Distribution
- U.S.: VA, IL
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580. Recalled by Merit Medical Systems, Inc.. Units affected: 24 kits.
Why was this product recalled? ▼
Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2019. Severity: Moderate. Recall number: Z-0027-2020.
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