Intuitive Surgical, Inc.: da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch

Is my product affected?

da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch

• UPC 00886874113486

Check against the official notice below — it lists the full affected range.

What happened

Intuitive Surgical, Inc. is recalling da Vinci SP Instrument Arm Drapes (Model Number 430013-12) because the drape may tear while being placed on the Patient Side Cart, which could compromise the sterile barrier needed during surgery. A total of 1,818 pouches across all lot numbers have been distributed to facilities in multiple states including Florida, Ohio, Tennessee, New Jersey, Pennsylvania, Maryland, New York, California, Minnesota, Nevada, Oregon, Hawaii, Virginia, Texas, Alabama, Illinois, Connecticut, and North Carolina, as well as to South Korea.

The recall notice does not specify a remedy or instructions for what affected consumers should do regarding this recalled product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.

Details from the source

Reason for recall: The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier. Distribution: Updated information provided on 03/18/2020: FL, OH, TN, NJ, PA, MD, NY, CA, MN, NV, OR, HI, VA, TX, AL, CA, IL, CN, and NC. OUS: APAC (Asia Pacific) - South Korea Quantity: 1818 pouches Lot/code info: Model Number: 430013-12 UDI Number: 00886874113486 Lot Numbers: All Lots

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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