Recall Z-3240-2017
The Metrix Company · initiated September 13, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
Codes / lots: UDI: 50812496011850, Lot Numbers: 28990, 29093, 29135, 29244.
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.
FDA-determined cause: Error in labeling
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.
Details
- Recall number
- Z-3240-2017
- Initiated
- September 13, 2017
- Posted by FDA
- September 29, 2017
- Terminated
- May 25, 2018
- Product code
- KPE – Container, I.V.
- Quantity
- 50 cases of 200 units
- Distribution
- AZ, MA, IL, FL
- Recalling firm
- The Metrix Company, Dubuque, IA