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MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF… recallZ-0508-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Oct 16, 2024

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

FDA root cause category: Under Investigation by firm

What the company is doing

An IMMEDIATE ACTION REQUIRED RECALL notification letter dated 10/16/24 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 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. 3.Upon receipt of your submitted response form, your account will receive over-labels to place unaffected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-216-FGRecall Code: 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. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-0508-2025
Status
Open, Classified
Initiated by the company
Oct 16, 2024
Posted by the FDA
Nov 22, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1975 units
Product code
CAZ
FDA submissions
K051171
Distribution
US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

Product description

MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector

Code information (models, lots, serial numbers)

UDI/DI 10193489490312 (each), 40193489490313 (case), Lot Numbers: 21ABD173, 21EBC720, 21GBG632, 21HBF316, 21IBH392, 21IBM516, 21JBJ902, 21JBP187, 22IBL115, 22KBD213, 22OBI434, 23ABA553, 23ABO991, 23BBG757, 23CBO551, 23EBT535

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 95615).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page