Da Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical System; Model IS2000, Part Numbers: 400
FDA device recall Z-1348-2008 · posted 2008-08-06 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- (1) Incorrect dimension on Luer on smoke evacuation cannulae not allowing for secure attachment function. (2) Incorrect labeling. External labeling lot number differs from lot number etched on the cannula.
- Action taken
- On 1/4/08, the firm initiated the recall and its notification was via Urgent Device Recall letters explaining the reason for the recall, requesting immediate discontinued use, segregate non-conforming product in a secure area, and a Customer Service Rep will make contact in order to arrange for the retrieval of the material.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 39 units
- Distribution
- Nationwide
- Date initiated
- 2008-01-04
- Date posted
- 2008-08-06
- Date terminated
- 2011-03-31
- Location
- Sunnyvale, CA
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