Recalls / —

—#146282

Product

Cordis PRECISE (R) RX Nitinol Stent System (Biliary)

FDA product code

NIM — Stent, Carotid

Device class

Class 3

Medical specialty

Unknown

PMA numbers

P030047

Affected lot / code info

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.

Why it was recalled

Inability to deploy the stent or partial stent deployment.

Root cause (FDA determination)

Component design/selection

Action the firm took

Cordis sent an Urgent Medical Device Recall (Removal) letter dated May 4, 2016, to all affected customers. Action to be taken by the customer: 1) Immediately check your inventory to confirm whether you have any units from affected lots in your possession. Identify and set aside any units from the affected lot in a manner that ensures the affected product will not be used. Check all storage and usage locations. 2) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. Note that you will receive multiple letters and Acknowledgement Forms if your facility received affected product at both a legacy Ship-To account number and a Cardinal Health Ship To account number at the same address. In that scenario, please sign and return both forms. 3) Return all affected products to the address listed on the form, with reference to Return Authorization Number ( i.e. RA #)#which is listed on the form. Replacement devices will be shipped after the affected product is returned. Consigned Inventory will also be replaced after the product is returned and an analysis of SKU mix needed to properly support the customer is conducted. 4) Share this letter with others in your facility who need to be made aware of this recall, including the areas in some facilities where these products are frequently used (see list above) Contact any other facilities that have been provided with units of affected lots. Maintain awareness of this notice until all affected product has been returned to Cordis. 5) Keep a copy of this notice with any affected product until returned. For questions related to assistance returning product or billing concerns or questions please contact your sales representative or Cordis Customer Service at 1-800-327-7714 Option 1, Monday through Friday from 7:00AM to 8:00 PM EDT.

Recalling firm

Firm

Cordis Corporation

Address

14201 Nw 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern

NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.

Timeline

Recall initiated

2016-05-04

Terminated

2019-07-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #146282. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.