FDAClass IIApril 9, 2014

Merit Custom Syringe Kit recall

Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.

Why was Merit Custom Syringe Kit recalled?

The products are labeled as sterile but were not sterilized.

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?

Lot Number H574228

Product
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Recalling firm
Merit Medical Systems, Inc.
Quantity
15
Distribution
Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
Recall date
April 9, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls