Fluid Management Set recall: Sterility Concern
Fluid Management Set. Catalog Number K08-MP5159A
Why was Fluid Management Set 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 Number: H996433
- Product
- Fluid Management Set. Catalog Number K08-MP5159A
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 178 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)