8mm, Large Hem-o-lok Clip Applier recall
8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Why was it recalled?
The source record does not provide a concise hazard summary.
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; 470230-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
- Product
- 8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 509 total units, all affected devices
- 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)