Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialy
Check against the official notice below — it lists the full affected range.
Teleflex Medical Inc. is recalling the Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, model REF PT-65509, after receiving reports that the device tip can separate during use. The recall affects approximately 14,583 units that were distributed worldwide, including throughout the United States and to Australia, Belgium, Canada, Chile, Czech Republic, Germany, Spain, France, Great Britain, Israel, Italy, South Korea, Kuwait, Netherlands, Panama, Philippines, Portugal, Saudi Arabia, and Turkey.
The affected devices are identified by specific lot numbers ranging from 13F20A0286 through 13F20J0378, with expiration dates between December 2021 and August 2022. The recall record does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The firm received reports indicating PTD tip separation during use.
Reason for recall: The firm received reports indicating PTD tip separation during use. Distribution: Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR. Quantity: 14583 units Lot/code info: Lot Number / UDI: 13F20A0286 / (01)00801902013156(17)211231(10)13F20A0286; Lot Number / UDI: 13F20A0426 / (01)00801902013156(17)211231(10)13F20A0426; Lot Number / UDI: 13F20A0640 / (01)00801902013156(17)220131(10)13F20A0640; Lot Number / UDI: 13F20B0141 / (01)00801902013156(17)220131(10)13F20B0141; Lot Number / UDI: 13F20B0276 / (01)00801902013156(17)220228(10)13F20B0276; Lot Number / UDI: 13F20B0353 / (01)00801902013156(17)220228(10)13F20B0353; Lot Number / UDI: 13F20B0424 / (01)00801902013156(17)220228(10)13F20B0424; Lot Number / UDI: 13F20C0352 / (01)00801902013156(17)220228(10)13F20C0352; Lot Number / UDI: 13F20C0425 / (01)00801902013156(17)220331(10)13F20C0425; Lot Number / UDI: 13F20C0426 / (01)00801902013156(17)220331(10)13F20C0426; Lot Number / UDI: 13F20D0122 / (01)00801902013156(17)220331(10)13F20D0122; Lot Number / UDI: 13F20D0123 / (01)00801902013156(17)220430(10)13F20D0123; Lot Number / UDI: 13F20D0124 / (01)00801902013156(17)220331(10)13F20D0124; Lot Number / UDI: 13F20D0403 / (01)00801902013156(17)220430(10)13F20D0403; Lot Number / UDI: 13F20E0204 / (01)00801902013156(17)220430(10)13F20E0204; Lot Number / UDI: 13F20F0232 / (01)00801902013156(17)220531(10)13F20F0232; Lot Number / UDI: 13F20F0389 / (01)00801902013156(17)220630(10)13F20F0389; Lot Number / UDI: 13F20G0353 / (01)00801902013156(17)220630(10)13F20G0353; Lot Number / UDI: 13F20H0729 / (01)00801902013156(17)220831(10)13F20H0729; Lot Number / UDI: 13F20J0378 / (01)00801902013156(17)220831(10)13F20J0378;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.