FDAFDA · Food and drugs·Recall number Z-2104-2012
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; 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.
Published August 8, 2012 · Recall initiated: July 13, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.
- Lot
- Part number: 420290-03 Lot numbers: D120735,,D120745,D120815, D120815A, D120885, D120895, D120905 D120945, D120955, D120955A, D120965, D121025, D121035, D121045, D121075, D121075A, D121095, D121155, D121165, D121165A, D121215.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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