SECURE recallZ-3240-2017 · The Metrix Company · initiated Sep 13, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from The Metrix Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Error in labeling
What the company is doing
Recall letters will be sent to each consignee (distributors) via FedEx. The letter requested the following: "The Metrix Company is asking all customers to follow the steps below: 1. Recalled products must not be used. 2. Locate and quarantine all affected products. 3. Destroy all affected products and dispose/recycle in a manner consistent with your local waste disposal authority. 4. Complete the Response form and return it to The Metrix Company according to the instructions on the form." Distributors were instructed to contact their customers about the recall. The product is to be destroyed in the field.
Recall details
- Recall number
- Z-3240-2017
- Status
- Terminated
- Initiated by the company
- Sep 13, 2017
- Posted by the FDA
- Sep 29, 2017
- Recalling firm
- The Metrix Company
- Quantity
- 50 cases of 200 units
- Product code
- KPE
- FDA submissions
- K843523
- Distribution
- AZ, MA, IL, FL
Product description
SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
Code information (models, lots, serial numbers)
UDI: 50812496011850, Lot Numbers: 28990, 29093, 29135, 29244.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SECURE® 58719Metrix Company, The · Container, I.V.1 recall2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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