Centurion Medical Products Corp recallZ-1995-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated May 15, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
FDA root cause category: Under Investigation by firm
What the company is doing
An URGENT MEDICAL DEVICE PRODUCT RECALL notification letter dated 5/15/25 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.comRecall Reference #: R-25-096-FGX2 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].
Recall details
- Recall number
- Z-1995-2025
- Status
- Open, Classified
- Initiated by the company
- May 15, 2025
- Posted by the FDA
- Jun 20, 2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 174 units
- Product code
- LRO
- Distribution
- US Nationwide distribution in the state of VA.
Product description
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Code information (models, lots, serial numbers)
UDI-DI: 10653160995340 (each), 40653160995341 (case); Lot Numbers: 25BBG881, 24KBU973, 24IBK851, 24HBQ012
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Centurion Medical Products Corp UVT1250Medline Industries, Inc. · General surgery tray2 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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