Recall archive / FDA device enforcement
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-0... — FDA record Z-0628-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 11, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) 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 dialysis grafts.
- Reason
- The firm received reports indicating PTD tip separation during use.
- Classification
- Class I
- Recalling firm
- TELEFLEX MEDICAL INC
- Quantity
- 5530 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0628-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Number / UDI: 13F20A0359 / (01)10801902121285(17)211231(10)13F20A0359, Components: Code PT-65509-S, Lot number 14C19H0644; Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19J0203; Code PT-01000-D, Lot number 13C19L2034; Lot Number / UDI: 13F20A0519 / (01)10801902121285(17)211131(10)13F20A0519, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19J0203; Code PT-03000, Lot number 13C19M0279; Code PT-01000-D, Lot number 13C20A0986; Lot Number / UDI: 13F20B0140 / (01)10801902121285(17)220131(10)13F20B0140, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19M0279; Code PT-03000, Lot number 13C19M0954; Code PT-01000-D, Lot number 13C20A2408; Lot Number / UDI: 13F20B0423 / (01)10801902121285(17)220228(10)13F20B0423, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19M0954; Code PT-03000, Lot number 13C20A0627; Code PT-01000-D, Lot number 13C20B1758; Lot Number / UDI: 13F20C0223 / (01)10801902121285(17)220228(10)13F20C0223, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19M0954; Code PT-03000, Lot number 13C20A0627; Code PT-01000-D, Lot number 13C20B2334; Lot Number / UDI: 13F20C0593 / (01)10801902121285(17)220331(10)13F20C0593, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-65509-S, Lot number 14C20C0858; Code PT-03000, Lot number 13C20A0627; Code PT-01000-D, Lot number 13C20B2334; Code PT-01000-D, Lot number 13C20C1557; Lot Number / UDI: 13F20D0128 / (01)10801902121285(17)220331(10)13F20D0128, Components: Code PT-65509-S, Lot number 14C20C0858; Code PT-65509-S, Lot number 14C20D0475; Code PT-03000, Lot number 13C20B0812; Code PT-01000-D, Lot number 13C20C1557; Code PT-01000-D, Lot number 13C20D1155; Lot Number / UDI: 13F20D0386 / (01)10801902121285(17)220331(10)13F20D0386, Components: Code PT-65509-S, Lot number 14C20D0475; Code PT-03000, Lot number 13C20C2655; Code PT-01000-D, Lot number 13C20D1155; Code PT-01000-D, Lot number 13C20D0848; Lot Number / UDI: 13F20F0576 / (01)10801902121285(17)220630(10)13F20F0576, Components: Code PT-65509-S, Lot number 14C20D0475; Code PT-65509-S, Lot number 14C20E0949; Code PT-03000, Lot number 13C20D1154; Code PT-01000-D, Lot number 13C20E0897; Lot Number / UDI: 13F20G0176 / (01)10801902121285(17)220630(10)13F20G0176, Components: Code PT-65509-S, Lot number 14C20E0949; Code PT-03000, Lot number 13C20G0231; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20G0235; Lot Number / UDI: 13F20J0139 / (01)10801902121285(17)220831(10)13F20J0139, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-65509-S, Lot number 14C20E0949; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20G035; Code PT-01000-D, Lot number 13C20G1571; Lot Number / UDI: 13F20J0547 / (01)10801902121285(17)220831(10)13F20J0547, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-03000, Lot number 13C20G1570; Code PT-03000, Lot number 13C20J0904; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20H2329; Code PT-01000-D, Lot number 13C20G1571; Lot Number / UDI: 13F20K0212 / (01)10801902121285(17)220930(10)13F20K0212, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-03000, Lot number 13C20J0904; Code PT-01000-D, Lot number 13C20H2329; Code PT-01000-D, Lot number 13C20E0897; Lot Number / UDI: 13F20L0160 / (01)10801902121285(17)221031(10)13F20L0160, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-03000, Lot number 13C20J2204; Code PT-01000-D, Lot number 13C20K0550; Code PT-01000-D, Lot number 13C20H2329; Code , Lot number; Lot Number / UDI: 13F20M0183 / (01)10801902121285(17)22123(10)13F20M0183, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-65509-S, Lot number 14C20K1044; Code PT-03000, Lot number 13C20J09904; Code PT-03000, Lot number 13C20J2204; Code PT-03000, Lot number 13C20K2183; Code PT-03000, Lot number 13C20L1808; Code PT-01000-D, Lot number 13C20K0550; Code PT-01000-D, Lot number 13C20H2329; Code PT-01000-D, Lot number 13C20M0603; Lot Number / UDI: 13F21B0224 / (01)10801902121285(17)230131(10)13F21B0224, Components: Code PT-65509-S, Lot number 14C20K1044; Code PT-65509-S, Lot number 14C20M0931; Code PT-03000, Lot number 13C20J0904; Code PT-03000, Lot number 13C20M0145; Code PT-03000, Lot number 13C21A0856; Code PT-03000, Lot number 13C20L1808; Code PT-01000-D, Lot number 13C20M0603; Code PT-01000-D, Lot number 13C20M0603; Code PT-01000-D, Lot number 13C20H2329; Lot Number / UDI: 13F21C0080 / (01)10801902121285(17)230228(10)13F21C0080, Components: Code PT-65509-S, Lot number 14C20M0931; Code PT-65509-S, Lot number 14C21B0685; Code PT-03000, Lot number 13C20M0145; Code PT-03000, Lot number 13C21A0856; Code PT-03000, Lot number 13C21B0561; Code PT-01000-D, Lot number 13C21B0563; Code PT-01000-D, Lot number 13C20H2329; Lot Number / UDI: 13F21C0366 / (01)10801902121285(17)230228(10)13F21C0366, Components: Code PT-65509-S, Lot number 14C20M0931; Code PT-65509-S, Lot number 14C21B0685; Code PT-03000, Lot number 13C21A0856; Code PT-01000-D, Lot number 13C21B0563; Code PT-01000-D, Lot number 13C20H2329; Lot Number / UDI: 13F21D0106 / (01)10801902121285(17)230331(10)13F21D0106, Components: Code PT-65509-S, Lot number 14C21B0685; Code PT-03000, Lot number 13C21A0856; Code PT-03000, Lot number 13C21B0561; Code PT-03000, Lot number 13C21C2403; Code PT-01000-D, Lot number 13C21C1154; Code PT-01000-D, Lot number 13C21B0563; Code PT-01000-D, Lot number 13C20H2329; Lot Number / UDI: 13X21D0026 / (01)10801902121285(17)230430(10)13X21D0026, Components: Code PT-65509-S, Lot number 14C21B0685; Code PT-65509-S, Lot number 14X21D0004; Code PT-03000, Lot number 13X21D0011; Code PT-01000-D, Lot number 13C21C1154; Code PT-01000-D, Lot number 13X21D0010; Lot Number / UDI: 13F21E0078 / (01)10801902121285(17)230430(10)13F21E0078, Components: Code PT-65509-S, Lot number 14C21B0685; Code PT-65509-S, Lot number 14C21D0123; Code PT-03000, Lot number 13C21D1120; Code PT-01000-D, Lot number 13C21C1154; Code PT-01000-D, Lot number 13C21C1693; Lot Number / UDI: 13F21E0557 / (01)10801902121285(17)230630(10)13F21E0557, Components: Code PT-65509-S, Lot number 14C21D0123; Code PT-65509-S, Lot number 14C21E0930; Code PT-65509-S, Lot number 14C21D1205; Code PT-65509-S, Lot number 14C21F1318; Code PT-03000, Lot number 13C21E1975; Code PT-03000, Lot number 13C21D1120; Code PT-03000, Lot number 13C21E1463; Code PT-01000-D, Lot number 13C21C1154; Code PT-01000-D, Lot number 13C21E0333; Lot Number / UDI: 13F21G1344 / (01)10801902121285(17)230731(10)13F21G1344, Components: Code PT-65509-S, Lot number 14C21F1318; Code PT-65509-S, Lot number 14R21D0123; Code PT-65509-S, Lot number 14R21D1205; Code PT-03000, Lot number 13C21E1463; Code PT-03000, Lot number 13C21E1975; Code PT-01000-D, Lot number 13C21E0333; Code PT-01000-D, Lot number 13C21E1985; Lot Number / UDI: 13F21H0213 / (01)10801902121285(17)230731(10)13F21H0213, Components: Code PT-65509-S, Lot number 14R21D1205; Code PT-65509-S, Lot number 14R21D1205; Code PT-65509-S, Lot number 14R21E0930; Code PT-03000, Lot number 13C21G0966; Code PT-03000, Lot number 13C21E1975; Code PT-01000-D, Lot number 13C21G0965; Code PT-01000-D, Lot number 13C21E1985; Lot Number / UDI: 13F21H0659 / (01)10801902194081(17)230831(10)13F21H0659, Components: Code PT-65509-S2, Lot number 14C21H0977; Code PT-03000-S, Lot number 13C21H1235; Code PT-01000-D2, Lot number 13C21H1234; Lot Number / UDI: 13F21J0455 / (01)10801902194081(17)230930(10)13F21J0455, Components: Code PT-65509-S2, Lot number 14C21H0977; Code PT-03000-S, Lot number 13C21H1235; Code PT-03000-S, Lot number 13C21J0983; Code PT-01000-D2, Lot number 13C21H1234; Code PT-01000-D2, Lot number 13C21J0982; Lot Number / UDI: 13F21K0897 / (01)10801902194081(17)231031(10)13F21K0897, Components: Code PT-65509-S2, Lot number 14C21H1311; Code PT-65509-S2, Lot number 14C21H0977; Code PT-03000-S, Lot number 13C21J0983; Code PT-01000-D2, Lot number 13C21J0982; Code PT-01000-D2, Lot number 13C21K1835; Lot Number / UDI: 13F21L0901 / (01)10801902194081(17)231130(10)13F21L0901, Components: Code PT-65509-S2, Lot number 14C21H1311; Code PT-65509-S2, Lot number 14C21K0161; Code PT-03000-S, Lot number 13C21J0983; Code PT-03000-S, Lot number 13C21K2035; Code PT-03000-S, Lot number 13C21L1102; Code PT-01000-D2, Lot number 13C21L1104 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 23, 2022
- Recall initiation date
- Jan 11, 2022
- Center classification date
- Feb 15, 2022
- Termination date
- Sep 11, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.