Procedure Kit recall: Sterility Concern
Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
Why was Procedure Kit recalled?
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
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 Numbers: H992344 and H996476
- Product
- Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 53 units
- Distribution
- Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
- Recall date
- November 30, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)