Recall Z-3240-2017— The Metrix Company

Name: FDA recall Z-3240-2017
Creator: U.S. Food and Drug Administration
Published: 2017-09-13

Class II · Terminated

Class II FDA medical device recall by The Metrix Company, initiated 2017-09-13, terminated 2018-05-25. It names one FDA 510(k) clearance: K843523. Product: SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,. Reason: The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes..

Recalling firm: The Metrix Company
Classification: Class II
Status: Terminated
Initiated: 2017-09-13
Terminated: 2018-05-25
Firm location: Dubuque, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K843523 — EMPTY SOLUTION TRANSFER CONTAINER 1000Polymer Technology Corp.·cleared 1984-10-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,

Reason for recall

The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.

Data sourced from openFDA. This site is unofficial and independent of the FDA.