Stryker Neurovascular recalls Distal Access Catheter (Lot #0000486382) due to out-of-specification endotoxin results. Affected units may pose a risk of infection or adverse reactions. Consumers should contact Stryker for details.
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.
Stryker Neurovascular is recalling a specific Distal Access Catheter model due to endotoxin levels that were outside acceptable specifications. This could potentially lead to infection or adverse reactions if used in medical procedures.
The catheter was manufactured with endotoxin levels outside the specified range. Endotoxins are bacterial components that can cause infections or adverse reactions when introduced into the body during medical procedures.
Healthcare professionals using the recalled Distal Access Catheter for medical procedures are most at risk. Patients receiving procedures with this catheter may also be affected.
Check for the UDI-DI: 07613327313895 and Lot number 0000486382 on the product label. The catheter has a hydrophilic coating and a rotating hemostasis valve with side-arm adapter.
Reach out to Stryker Neurovascular for specific instructions on how to return or dispose of the recalled catheter.
The catheter was manufactured with endotoxin levels outside the specified range, which could lead to infection or adverse reactions during medical procedures.
Contact Stryker Neurovascular for specific instructions on how to return or dispose of the recalled catheter.
The recall is due to potential infection or adverse reactions, not immediate serious injury risks. The danger level is low risk.
We’ve drafted a message you can send Stryker Neurovascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1740-2024 — Stryker Neurovascular Stryker Neurovascular Hello, I own a Stryker Neurovascular that is covered by recall Z-1740-2024 from Stryker Neurovascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
