Palindrome H Chronic 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 approximately 26,474 units of Palindrome H Chronic Catheters used for hemodialysis, apheresis, and infusion procedures. The catheters may have a leaking condition in the hub due to an internal void in the hub component, which could cause unexpected fluid to leak back during use. The affected catheters were distributed worldwide and throughout the United States, as well as in multiple international locations.
The recalled catheters are identified by specific model numbers, serial numbers, and product codes listed in the recall notice. The source document does not specify what actions affected consumers should take in response to this recall.
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: 26,474 units Lot/code info: Code Information organized as "Model No., Serial No., GTIN": 8888119365, 1925200097, 20884521012810; 8888119371, 2031800117, 20884521056562; 8888123405, 2028200168, 20884521012940; 8888123405, 2127200428, 20884521012940; 8888145043, 1932200082, 10884521013223; 8888145043, 2003700042, 10884521013223; 8888145043, 2014900147, 10884521013223; 8888145043, 2023300169, 10884521013223; 8888145043, 2031800113, 10884521013223; 8888145043, 2034400185, 10884521013223; 8888145043, 2104600104, 10884521013223; 8888145043, 2108100054, 10884521013223; 8888145043, 2127200539, 10884521013223; 8888145043, 1919700110, 20884521013220; 8888145043, 1929500076, 20884521013220; 8888145043, 1932200082, 20884521013220; 8888145043, 2000700103, 20884521013220; 8888145043, 2003700042, 20884521013220; 8888145043, 2014900147, 20884521013220; 8888145043, 2019200001, 20884521013220; 8888145043, 2023300169, 20884521013220; 8888145043, 2028200174, 20884521013220; 8888145043, 2031800112, 20884521013220; 8888145043, 2031800113, 20884521013220; 8888145043, 2034400185, 20884521013220; 8888145043, 2034400187, 20884521013220; 8888145043, 2104600100, 20884521013220; 8888145043, 2104600104, 20884521013220; 8888145043, 2108100054, 20884521013220; 8888145043, 2108100055, 20884521013220; 8888145043, 2108100056, 20884521013220; 8888145043, 2109700070, 20884521013220; 8888145043, 2116500163, 20884521013220; 8888145043, 2124500119, 20884521013220; 8888145043, 2127200539, 20884521013220; 8888145043, 2127200540, 20884521013220;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.