medical Class II Updated 2024-11-20

Stryker Corporation recalls Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-

Recalled Product

Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - 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. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Catalog Number: 0703-046-002

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 07613327379488 Lot Numbers: 53864143 57458172 58761873 63837701 64258041 65777003 66126554 66751061 68311144 54406823 57458173 58761874 63837702 64258042 65777004 66487383 67200500 68311145 54406824 57458174 60308898 63866394 64258044 65954742 66487384 67200501 68672590 54406825 57458175 60308899 63866395 64850548 65954743 66487385 67200502 68728239 54406826 57694644 62291709 64052771 64850549 65954744 66487386 67715714 68728240 54406827 57733684 62377382 64112622 64968511 65954745 66751059 67787217 54406828 58009712 62537206 64112623 64968512 66126553 66751060 68200024
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