Recall Z-3240-2017 ยท KPE Container, I.V.
The Metrix Company
SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
| Date | Sep 29, 2017 (initiated Sep 13, 2017) |
| Status | Terminated |
| 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. |
| Root cause | Error in labeling |
| 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 des |
| Quantity | 50 cases of 200 units |
| Distribution | AZ, MA, IL, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K843523 | EMPTY SOLUTION TRANSFER CONTAINER 1000 Polymer Technology Corp., Oct 16, 1984 |