Reported Sep 23, 2015 · Terminated
Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01,…
Intuitive Surgical, Inc.
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: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 100 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems
- Model numbers
950156-01950156-02950156-03
- Product UsageGeneral
- and plastic surgeryThe da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 950156-02Lot numbers: NQ141201 NQ141502 NQ142201 NQ142901 NQ143201 NQ143301. 950156-03Lot numbers: NQ143501 NQ143502 NQ143601 NQ143602 NQ143803 NQ143901 NQ143902. — Lot numbers : NQ144001 NQ150501 NQ143902 NQ150601 NQ143901 NQ150602 NQ143803 NQ150703 NQ143601 NQ150701 NQ143602 NQ150702 NQ144502 NQ150801 NQ144801 NQ150901 NQ145202 NQ150802 NQ144901 NQ151001 NQ145301 NQ151002 NQ145201 NQ151101 NQ150301 NQ150501 NQ144001. - Amount recalled
- 1200 kits
Where it was sold
- Nationwide
Why it was recalled
B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks.
This product could cause temporary or reversible health problems — stop using it.
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