Reported Nov 20, 2024 · Ongoing
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general…
Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Corporation · 1941 Stryker Way · Portage, MI · 49002-9711
Is this the product you have?
- 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 Number0703-046-002
- Lot codes and dates
- GTIN07613327379488
- Lot Numbers
61 of 61 codes
538641435745817258761873638377016425804165777003661265546675106168311144544068235745817358761874638377026425804265777004664873836720050068311145544068245745817460308898638663946425804465954742664873846720050168672590544068255745817560308899638663956485054865954743664873856720050268728239544068265769464462291709640527716485054965954744664873866771571468728240544068275773368462377382641126226496851165954745667510596778721754406828580097126253720664112623649685126612655366751060
- Amount recalled
- 403,730 eaches
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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