Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling approximately 213,589 units of Palindrome Precision Chronic Catheters used for vascular access in hemodialysis, apheresis, and infusion procedures. The recalled catheters have a potential leaking condition in the hub caused by an inter-lumen void in the hub component. This defect may cause unanticipated fluid return during use of the catheter.
The affected catheters were distributed worldwide, including throughout all U.S. states and territories, and internationally to countries including Argentina, Australia, Austria, the Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, and Brunei, among others. Specific lot and serial numbers are identified in the recall notice. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
Reason for recall: There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darus Quantity: 213,589 units Lot/code info: Code Information organized as "Model No., Serial No., GTIN": 8888123400, 1729700111, 20884521012933; 8888123400, 1831000130, 20884521012933; 8888123400, 1904600085, 20884521012933; 8888133500, 2012100128, 20884521013060; 8888119360P, 2007800129, 10884521157699; 8888119360P, 2034400078, 10884521157699; 8888119360P, 1720000102, 20884521157696; 8888119360P, 1904200103, 20884521157696; 8888119360P, 1923400228, 20884521157696; 8888119360P, 1932300203, 20884521157696; 8888119360P, 2007800129, 20884521157696; 8888119360P, 2034400078, 20884521157696; 8888119360P, 2104600179, 20884521157696; 8888119360P, 2110900110, 20884521157696; 8888119360P, 2113300438, 20884521157696; 8888119360P, 2127700068, 20884521157696; 8888119364P, 1925200093, 10884521157705; 8888119364P, 1934400186, 10884521157705; 8888119364P, 2019500171, 10884521157705; 8888119364P, 2020400088, 10884521157705; 8888119364P, 2028200217, 10884521157705; 8888119364P, 2034400079, 10884521157705; 8888119364P, 2034400115, 10884521157705; 8888119364P, 2034400123, 10884521157705; 8888119364P, 2104600111, 10884521157705; 8888119364P, 2119300075, 10884521157705; 8888119364P, 2119700074, 10884521157705; 8888119364P, 1832300117, 20884521157702; 8888119364P, 1914800155, 20884521157702; 8888119364P, 1914800159, 20884521157702; 8888119364P, 1914800160, 20884521157702; 8888119364P, 1917200272, 20884521157702; 8888119364P, 1921300039, 20884521157702; 8888119364P, 1921300040, 20884521157702; 8888119364P, 1925200092, 20884521157702; 88881193
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.