RecallRadar

FDA Device recall Z-1319-2014

Pressure Monitoring Tubing, PM6006

On 2014-04-09 the FDA classified a Class II recall of Pressure Monitoring Tubing, PM6006 by Merit Medical Systems, citing the products are labeled as sterile but were not sterilized.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1319-2014
ClassificationClass II
Statusterminated
Initiated2014-03-13
Published2014-04-09
Last updated2026-09-13 11:53 UTC
CompanyMerit Medical Systems
DistributionUS

Product

Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.

Reason

The products are labeled as sterile but were not sterilized.

Identifiers

code_infoLot Number H591335

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1319-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.