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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 62553
Product Type Devices
Status Ongoing
Recalling Firm Intuitive Surgical, Inc.
City Sunnyvale
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-13
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
INSTRUMENT ARM DRAPE IS2000, 20 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. Part number: 420015-03; Lot numbers: D120745A, D120765, D120795, D120845, D120895A, D120935, D120955. Class II Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. 89670 total instrument Drapes Z-2101-2012
KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 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. Part number: 420256-01 Lot numbers: D120745, D120755, D120835, D120865. Class II Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. 89670 total instrument Drapes Z-2102-2012
KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 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. Part number: 420258-01 Lot numbers: D120755 ,D120755A , D120825. Class II Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. 89670 total instrument Drapes Z-2103-2012
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. 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. Class II Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. 89670 total instrument Drapes Z-2104-2012
KIT,DISPOSABLE ACCESSORY,4ARM,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. Part number: 420291-03 Lot numbers: D120795 ,D120795A , D120805, D120815, D120875, D120885, D120885A, D120935, D120935A,D120945 D121015 D121025 D121025A D121105 D121105A D121355A Class II Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. 89670 total instrument Drapes Z-2105-2012
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. Part number: 380595-02 Lot numbers: 298601, 298602, 298608, 298613, 298625, 298627, 298629. Class II Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument. 89670 total instrument Drapes Z-2106-2012
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