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Sheath, 18 Fr., 160 mm (REF: WA2PS18L)… recallZ-0716-2025 · Trokamed GmbH · initiated Nov 27, 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 Trokamed GmbH 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

If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.

FDA root cause category: Labeling False and Misleading

What the company is doing

On November 27, 2024, a "URGENT SAFETY FIELD NOTICE" email was sent to the distributor. Actions to be taken: - Inform the medical personnel using the product about the update of the IFU: 1. The Instructions for Use has to be exchanged. 2. Complete the enclosed acknowledgement of receipt and email to [email protected] by the provided date. - Please be informed that the assumption of risks is on your behalf when you will not send back the acknowledgement by the provided date. Disclosure of the information described herein: Please ensure in your organization that all users of the above-mentioned products and other persons to be informed are made aware of this Urgent Field Safety Notice. If you have given the products to third parties, please forward a copy of this information or inform the contact person indicated below. Please keep this information at least until the action has been completed. If you have any questions or concerns about this notification, please contact the Quality Management Representative at +49 7704 9244 60. ***Updated 2/5/2025*** On 01/14/2025 an updated "URGENT SAFETY FIELD NOTICE" letter was sent to their distributor account. What measures are to be taken by the recipient? 1. Inform the medical personnel using the product about this field safety notice. 2. Replace your current Instructions for Use for this device with the updated version provided (W9229406_01). This is not a product removal action. You may continue to use the device as per this letter and the updated Instruction for Use. 3. Acknowledge receipt according to the instructions provided by your local distributor. Please ensure in your organization that all users of the above-mentioned products and other persons to be informed are made aware of this Urgent Field Safety Notice. If you have given the products to third parties, please forward a copy of this information or inform the contact person indicated below. Please keep this information at least until the action has been

Recall details

Recall number
Z-0716-2025
Status
Open, Classified
Initiated by the company
Nov 27, 2024
Posted by the FDA
Jan 10, 2025
Recalling firm
Trokamed GmbH
Quantity
102 units
Product code
FED
FDA submissions
K200770
Distribution
US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. .

Product description

Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.

Code information (models, lots, serial numbers)

REF: WA2PS18L; UDI-DI: 04251303810872; Lot Numbers: 154214

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 95770).

Sources and updates

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