Merit Medical Systems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0631-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Fluid Management Set. Catalog Number K08-MP5159A

Product Classification:

Class II

Date Initiated: September 23, 2016

Date Posted: November 30, 2016

Recall Number: Z-0631-2017

Event ID: 75367

Reason for Recall:

Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.

Status: Terminated

Product Quantity: 178 units

Code Information:

Lot Number: H996433

Distribution Pattern:

Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.

Voluntary or Mandated:

Voluntary: Firm initiated