Prestige Plus 185cm J-Tip recall: Labeling Error
Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels…
Why was Prestige Plus 185cm J-Tip recalled?
During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
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?
Product number 9185J; lot number 50004551/005-060, serial numbers 005-060.
- Product
- Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels…
- Recalling firm
- Volcano Corporation
- Quantity
- 162 total (both devices)
- Distribution
- US Nationwide Distribution and one account in Canada.
- Recall date
- July 1, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)