da Vinci SP Instrument Arm Drape recall: Sterility Concern
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Why was da Vinci SP Instrument Arm Drape recalled?
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 430013-12 UDI Number: 00886874113486 Lot Numbers: All Lots
- Product
- da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 1818 pouches
- 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
- Recall date
- May 13, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)