PlainRecalls
FDA Devices Moderate Class II Terminated

Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G

Reported: November 30, 2016 Initiated: September 23, 2016 #Z-0634-2017

Product Description

Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G

Reason for Recall

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

Details

Units Affected
130 units
Distribution
Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
Location
South Jordan, UT

Frequently Asked Questions

What product was recalled?
Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G. Recalled by Merit Medical Systems, Inc.. Units affected: 130 units.
Why was this product recalled?
Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 30, 2016. Severity: Moderate. Recall number: Z-0634-2017.