Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Reported: April 9, 2014 Initiated: March 13, 2014 #Z-1320-2014
Product Description
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Reason for Recall
The products are labeled as sterile but were not sterilized.
Details
- Recalling Firm
- Merit Medical Systems, Inc.
- Units Affected
- 15
- Distribution
- Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.. Recalled by Merit Medical Systems, Inc.. Units affected: 15.
Why was this product recalled? ▼
The products are labeled as sterile but were not sterilized.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 9, 2014. Severity: Moderate. Recall number: Z-1320-2014.
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