Palindrome 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 576,018 units of Palindrome Chronic Catheters used for vascular access in hemodialysis, apheresis, and infusion procedures. The catheters have a potential leaking condition in the hub component caused by an inter-lumen void, which may cause unanticipated fluid to leak during use. The affected catheters were distributed worldwide and throughout all U.S. states, territories, and multiple countries, with specific lot numbers and serial numbers identified in the recall notice.
The source document does not specify a remedy for consumers who have this product.
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: 576,018 units Lot/code info: Code Information organized as "Model No., Serial No., GTIN": 8888119360, 1916500132, 20884521012803; 8888119364, 1831000099, 20884521056555; 8888119364, 1832300114, 20884521056555; 8888119364, 2019500276, 20884521056555; 8888119364, 2106900226, 20884521056555; 8888123404, 1912600108, 20884521056586; 8888123404, 1934400172, 20884521056586; 8888123404, 2012100136, 20884521056586; 8888123404, 2017500130, 20884521056586; 8888123404, 2034400075, 20884521056586; 8888123404, 2104600236, 20884521056586; 8888123404, 2125800094, 20884521056586; 8888123404, 2127200415, 20884521056586; 8888123410, 2019500253, 20884521012988; 8888123410, 2104100079, 20884521012988; 8888128450, 2127200431, 20884521013008; 8888128454, 2017800061, 10884521056619; 8888128454, 1822600121, 20884521056616; 8888128454, 2017800061, 20884521056616; 8888128460, 2019500266, 20884521013053; 8888145014, 1715100153, 10884521013148; 8888145014, 1715800117, 10884521013148; 8888145014, 1715900177, 10884521013148; 8888145014, 1716100154, 10884521013148; 8888145014, 1717200138, 10884521013148; 8888145014, 1717400127, 10884521013148; 8888145014, 1717900133, 10884521013148; 8888145014, 1718600101, 10884521013148; 8888145014, 1719300100, 10884521013148; 8888145014, 1719800114, 10884521013148; 8888145014, 1720000100, 10884521013148; 8888145014, 1720700111, 10884521013148; 8888145014, 1721300160, 10884521013148; 8888145014, 1723400096, 10884521013148; 8888145014, 1724900105, 10884521013148; 8888145014, 1726300130, 10884521013148;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.