Stryker Corporation Recall 95502
Description: Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-046-001
Stryker Corporation Recall 95502 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0369-2025 |
| Event ID | 95502 |
| Event Description | Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. Catalog Number: 0703-046-001 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia. |
| Quantity | 21,490 eaches |
| Recall Reason | There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries |
| Device Classification | 20241120 |
| Device Code Info | GTIN: 07613327117196 Lot Numbers: 53867671 54409847 59053476 64855502 66494932 |
| Center Classification Date | 20241113 |
| Recall Initiation Date | 20241004 |
| Recalling Firm | Stryker Corporation |
| Initial Notification | Letter |
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