Z-1995-2025Class II

Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250

Name: Z-1995-2025 Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-05-15
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-05-15 / Open, Classified / root cause: packaging

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250 on 2025-05-15. FDA classified it as Class II and gives the reason as "There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1995-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-15
Posted: 2025-06-20
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Product code: LRO General Surgery Tray
Reason for recall: There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 174 units
Distribution: US Nationwide distribution in the state of VA.
Product codes and lots: UDI-DI: 10653160995340 (each), 40653160995341 (case); Lot Numbers: 25BBG881, 24KBU973, 24IBK851, 24HBQ012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1995-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1995-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-20

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)