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Stryker Corporation Recall 95502

Description: Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - 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: 0703-047-001

Stryker Corporation Recall 95502 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0367-2025
Event ID95502
Event DescriptionStryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - 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: 0703-047-001
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
Quantity2,620 eaches
Recall ReasonThere 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 Classification20241120
Device Code InfoGTIN: 07613327117219 Lot Number: 64117291
Center Classification Date20241113
Recall Initiation Date20241004
Recalling FirmStryker Corporation
Initial Notification Letter
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