SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
FDA device recall Z-3240-2017 · posted 2017-09-29 · Terminated
Recall details
- Recalling firm
- The Metrix Company
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KPE
- Quantity affected
- 50 cases of 200 units
- Distribution
- AZ, MA, IL, FL
- Date initiated
- 2017-09-13
- Date posted
- 2017-09-29
- Date terminated
- 2018-05-25
- Location
- Dubuque, IA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMPTY SOLUTION TRANSFER CONTAINER 1000 (K843523) | Polymer Technology Corp. | 1984-10-16 |