Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.
Check against the official notice below — it lists the full affected range.
Cordis Corporation is recalling 511 units of the Cordis S.M.A.R.T. Flex Biliary Stent System due to the potential for cracked luer hubs. This device is used to treat malignant strictures in the biliary tree. The affected products were distributed worldwide and throughout numerous U.S. states and territories, including Michigan, Alabama, Arkansas, California, Colorado, Florida, Georgia, Illinois, Iowa, Louisiana, Mississippi, New Jersey, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, West Virginia, Wisconsin, New York, Massachusetts, Nevada, Rhode Island, Indiana, Washington, Arizona, Washington D.C., Puerto Rico, and Canada.
The recall involves multiple lot numbers across various product codes and catalog numbers. The source document does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for cracked luer hubs
Reason for recall: Potential for cracked luer hubs Distribution: Worldwide Distribution - US Nationwide in the states of MI, AL, AR, CA, CO, FL, GA, IL, IA, LA, MS, NJ, NC, OH, OK, OR, PA, TN, TX, VA, WV, WI, MI, NY, MA, NV, RI, IN, WA, AZ, DC, Puerto Rico and the country of Canada. Quantity: 511 Lot/code info: GTIN Catalog Lot Numbers ------------------------------------------------------------------------------------------------ 20705032065600 SF05100MB 41316 and 41352, 20705032065648 SF06100MB 41318 and 41353, 20705032065723 SF06120MB 40997 and 41354, 20705032066034 SF06150MB 41198 and 41355, 20705032065747 SF07080MB 41319, 20705032065655 SF07100MB 40999 and 41199, 20705032065617 SF07150MB 41200 and 41356, 20705032065662 SF08100MB 41320, 20705032066348 SF08120MB 41056, 20705032066171 SF09030MB 41055, 20705032066164 SF09030SB 41203, 20705032066263 SF09060MB 41003 and 41359, 20705032065938 SF09060SB 41122, 20705032066096 SF09080MB 40998, 20705032066072 SF09080SB 41004 and 41202, 20705032065778 SF09100SB 40996 and 41124, 20705032065570 SF10040SB 41322, 20705032065945 SF10060SB 41002, 20705032066089 SF10080SB 41323, and 20705032066317 SF10100MB 41058.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.