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Class 2 Device Recall Distal Access Catheter |
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Date Initiated by Firm |
April 03, 2024 |
Date Posted |
May 01, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1740-2024 |
Recall Event ID |
94347 |
510(K)Number |
K133177
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Product Classification |
Catheter, percutaneous - Product Code DQY
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Product |
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rotating hemostasis valve is typically y shaped with a female luer lock and a manual hemostasis valve. The female port allows for aspiration and contrast injections while the hemostasis valve allows direct arterial access when using other devices such as guidewires and/or interventional devices. |
Code Information |
UDI-DI: 07613327313895, Lot: 0000486382, Expiration: 17-Jul-2025 |
Recalling Firm/ Manufacturer |
Stryker Neurovascular 47900 Bayside Pkwy Fremont CA 94538-6515
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Manufacturer Reason for Recall |
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.
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FDA Determined Cause 2 |
Release of Material/Component prior to receiving test results |
Action |
On 4/3/24, recall notices were mailed to Supply Chain Management/ Recall Coordinator/ Inventory Managers informing them:
1) Segregate the affected units in a secure location for return to the firm. Circulate this Recall-Removal notice internally to all interested/affected parties.
2) Maintain awareness of this communication internally until all required actions have been completed within your facility.
3) Inform the firm if any of the subject devices have been distributed to other organizations. If yes, provide contact details so the firm can inform the recipients appropriately.
4) Inform the firm of any adverse events concerning the use of the subject devices. (US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: NVCustomerCare@stryker.com)
5) Complete and return the customer response form to nvfieldactions@stryker.com |
Quantity in Commerce |
43 |
Distribution |
US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL. |
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 = DQY and Original Applicant = CONCENTRIC MEDICAL, INC.
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