Intuitive Surgical Recalls Fluorescence Imaging Kits Due to Packaging Damage
Intuitive Surgical is recalling 1,200 Fluorescence Imaging Procedure Kits because shipping damage may have compromised the sterile packaging of the stopcocks.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential breach of sterility in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling 1,200 Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems. The affected model numbers are 950156-01, 950156-02, and 950156-03. These kits are intended to provide real-time endoscopic visible and near-infrared fluorescence imaging for general and plastic surgery.
The recall was initiated because the B. Braun 2 gang 4-way stopcocks included in the kits may have experienced damage to their sterile packaging during shipping. This damage can result in tears to the packaging, which has the potential to cause a breach in the sterility of the supplied stopcocks.
The affected products were distributed nationwide in the United States. Specific lot numbers for each product number are listed in the official recall documentation. Healthcare facilities and consumers should stop using the affected kits and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and…
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,200
Distribution
Distributed nationwide across the United States.
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