Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Check against the official notice below — it lists the full affected range.
Covidien LLC has recalled 132,443 units of Mahurkar Chronic Carbothane (Maxid) Catheters used for hemodialysis, apheresis, and infusion. The catheters contain a potential leaking condition in the hub due to an inter-lumen void in the hub component, which may cause unanticipated fluid return during use.
The affected catheters were distributed worldwide, including across all U.S. states, territories, and numerous countries. The specific affected lots are identified by model numbers, serial numbers, and GTINs listed in the recall record. The source record does not specify a remedy or action that affected consumers should take.
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: 132,443 units Lot/code info: Code Information organized as "Model No., Serial No., GTIN": 8888119362, 1928800230, 10884521056879; 8888119362, 1825400094, 20884521056876; 8888119362, 1912600107, 20884521056876; 8888119362, 1917600139, 20884521056876; 8888119362, 1917700080, 20884521056876; 8888119362, 1925200098, 20884521056876; 8888119362, 1927300146, 20884521056876; 8888119362, 1928800230, 20884521056876; 8888119362, 2023300144, 20884521056876; 8888119362, 2028200216, 20884521056876; 8888119362, 2122900239, 20884521056876; 8888119385, 1720700105, 20884521012421; 8888119385, 1724900109, 20884521012421; 8888119385, 2113300429, 20884521012421; 8888123402, 1927500121, 10884521056886; 8888123402, 2028200203, 10884521056886; 8888123402, 2110900059, 10884521056886; 8888123402, 1921700145, 20884521056883; 8888123402, 1924000138, 20884521056883; 8888123402, 1925200091, 20884521056883; 8888123402, 1927500120, 20884521056883; 8888123402, 1927500121, 20884521056883; 8888123402, 2023300143, 20884521056883; 8888123402, 2026000055, 20884521056883; 8888123402, 2028200203, 20884521056883; 8888123402, 2034400155, 20884521056883; 8888123402, 2104100105, 20884521056883; 8888123402, 2110900059, 20884521056883; 8888123402, 2113300432, 20884521056883; 8888123402, 2122900252, 20884521056883; 8888123435, 2034400156, 10884521012516; 8888123435, 1716500170, 20884521012513; 8888123435, 1716700115, 20884521012513; 8888123435, 1825400095, 20884521012513; 8888123435, 1831000101, 20884521012513; 8888123435, 2003700038, 20884521012513;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.