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Terminated

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

FDA Recall Z-3240-2017 · Posted 2017-09-29

Recalling FirmThe Metrix Company
Recall StatusTerminated
Product CodeKPE
Date Initiated2017-09-13
Date Terminated2018-05-25
Product Quantity50 cases of 200 units

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.

Firm Action

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.

Root Cause

Error in labeling

Distribution Pattern

AZ, MA, IL, FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K843523EMPTY SOLUTION TRANSFER CONTAINER 1000Polymer Technology Corp. · 1984-10-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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