8mm,prograsp Forceps recall: Impurity Out of Spec
8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Why was 8mm,prograsp Forceps recalled?
Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
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?
Part number: 470093-04 ; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
- Product
- 8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- N/A
- Distribution
- US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
- Recall date
- December 3, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)