Intuitive Surgical Recalls Instrument Arm Drapes Due to Adaptor Engagement Issues
Intuitive Surgical is recalling specific lots of Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument during surgery.
What this means for you
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 is classified as FDA Class II, and the hazard involves a risk of harm (failure to maintain a sterile field) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling specific lots of the ACCESSORY BASE STARTER KIT, IS3000, which includes Instrument Arm Drapes. The intended use of these drapes is to protect equipment from contamination and maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
The recall is being issued because specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. This defect could potentially compromise the sterile field or equipment protection during use.
A total of 92,390 instrument drapes are affected. The products were distributed worldwide, including the United States, Australia, Spain, India, Italy, and Saudi Arabia. The affected part number is 380595-02, and the specific lot numbers are 298601, 298602, 298608, 298613, 298625, 298627, and 298629. Healthcare facilities should check their inventory for these specific lot numbers and contact Intuitive Surgical for instructions on how to return or replace the affected units.
The recalled product
- Product
- ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical Drapes
- Affected units
- 92,390
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Part number: 380595-02 Lot numbers: 298601
- 298602
- 298608
- 298613
- 298625
- 298627
- 298629.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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