Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
Recall
- Recall Number
- Z-2670-2025
- Event Number
- 97555
- FEI Number
- 1417592
- Product Code
- OEZ
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- August 21, 2025
- Posted
- October 1, 2025
- Address
- 3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753
Description
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
The kits contain certain lots of cannula products where the catheter may not retain its shape.
An URGENT MEDICAL DEVICE RECALL notification dated 8/21/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com. Recall Reference #: R-25-181-FGX1 Recall Code: 3. Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
US Nationwide distribution in the state of CA.
828 units