| Date Initiated by Firm | November 27, 2024 |
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| Date Posted | January 10, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0716-2025 |
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| Recall Event ID |
95770 |
| 510(K)Number | K200770 |
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| Product Classification |
endoscopic access overtube, gastroenterology-urology - Product Code FED
|
| Product | Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube. |
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| Code Information |
REF: WA2PS18L; UDI-DI: 04251303810872; Lot Numbers: 154214 |
| FEI Number |
3004595684
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Recalling Firm/
Manufacturer |
Trokamed GmbH
Kleine Breite 17
Geisingen Germany
|
Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Labeling False and Misleading |
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| Action | 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 anna.speker@trokamed.de 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 |
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| Quantity in Commerce | 102 units |
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| Distribution | US (Domestic) distribution in state of PA and OUS (foreign) to country of Germany. . |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = FED
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