medical Class I Updated 2022-07-13

Covidien Llc recalls Palindrome Precision SI Chronic Catheter, Sterile, Single Us

Recalled Product

Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Code Information organized as "Model No., Serial No., GTIN": 8888119368, 1925200090, 20884521012841; 8888119368, 1933700094, 20884521012841; 8888119368, 2001400077, 20884521012841; 8888119368, 2026000056, 20884521012841; 8888123408, 2009400114, 20884521012957; 8888128458, 1935100068, 20884521013039; 8888133508, 2026000060, 20884521013107; 8888145062, 2031800153, 10884521013407; 8888145062, 1933700095, 20884521013404; 8888145062, 2009400116, 20884521013404; 8888145062, 2031800131, 20884521013404; 8888145062, 2031800153, 20884521013404; 8888145063, 2000700056, 20884521013428; 8888145063, 2009400113, 20884521013428; 8888145063, 2027200181, 20884521013428; 8888145064, 2030100077, 20884521013442; 8888145065, 2026000067, 20884521013466; 8888145066, 2011900104, 10884521013476; 8888145066, 2019500162, 10884521013476; 8888145066, 2011900104, 20884521013473; 8888145066, 2019500162, 20884521013473
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