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Medline ReNewal Reprocessed Livewire Steerable… recallZ-1460-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Feb 6, 2025

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

Devices may have higher than expected amounts of bacterial endotoxin.

FDA root cause category: Under Investigation by firm

What the company is doing

An IMMEDIATE ACTION REQUIRED notification letter dated 2/6/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item numbers and the affected lot numbers listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product, please complete and return the form, as indicated on the response form. When we receive your completed response form you will be sent FedEx return labels to return the product back to Medline ReNewal (if applicable). Your account will receive credit or replacement when the returned product is received. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline ReNewal. If you have any questions, please contact 866-359-1704.

Recall details

Recall number
Z-1460-2025
Status
Open, Classified
Initiated by the company
Feb 6, 2025
Posted by the FDA
Mar 26, 2025
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
74 units
Product code
NLH
FDA submissions
K221067
Distribution
US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI.

Product description

Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R

Code information (models, lots, serial numbers)

401582R UDI-DI: 10888277407510 (each) 20888277407517 (case), Lot Number: EP240528; 401904R UDI-DI: 10888277407602 (each) 20888277407609 (case), Lot Number: EP240528; 401904R UDI-DI: 10888277407510 (each) 20888277407609 (case), Lot Number: EP240805; 401905R UDI-DI: 10888277407510 (each) 20888277407616 (case), Lot Number: EP240528; 401933R UDI-DI: 10888277407688 (each) 20888277407685 (case), Lot Number: EP240528; 401991R UDI-DI: 10888277407756 (each) 20888277407753 (case), Lot Number: EP240528;

Devices named in this recall

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

Other devices under the same FDA submission

27 devices cleared under K221067 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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