Z-3240-2017 Class II Terminated

Recalled by The Metrix Company — Dubuque, IA

FDA device recall Z-3240-2017 was initiated by The Metrix Company on September 13, 2017 and is designated Class II. 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. The recall status is terminated (terminated May 25, 2018). Affected quantity: 50 cases of 200 units.

Recall Details

Product Type
Devices
Report Date
October 11, 2017
Initiation Date
September 13, 2017
Termination Date
May 25, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
50 cases of 200 units

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.

Distribution Pattern

AZ, MA, IL, FL

Code Information

UDI: 50812496011850, Lot Numbers: 28990, 29093, 29135, 29244,