Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-3240-2017

September 13, 2017

Class II

Product summary

Firm
The Metrix Company
Event
Event 78117
Status
Terminated
Classification
Class II
Quantity
50 cases of 200 units
Official record key
device-enforcement:Z-3240-2017

Official wording

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.

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

Distribution pattern: AZ, MA, IL, FL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.