Cordis PRECISE recall
Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
Why was Cordis PRECISE recalled?
Inability to deploy the stent or partial stent deployment.
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?
Catalog Number: P05030RXB, Lot Number: 17241836; Catalog Number: P09030RXB, Lot Number: 17241838; Catalog Number: P07030RXB, Lot Number : 17291878; Catalog Number: P07040RXB, Lot Number: 17291879; Catalog Number: P06040RXB, Lot Number: 17415243.
- Product
- Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
- Recalling firm
- Cordis Corporation
- Quantity
- 4,400 units in US; 3,100 units to Foreign Countries
- Distribution
- NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
- Recall date
- June 22, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)