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5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC contain...

FDA Device Recall #Z-0628-2022 — Class I — January 11, 2022

Recall Summary

Recall Number Z-0628-2022
Classification Class I — Serious risk
Date Initiated January 11, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm TELEFLEX MEDICAL INC
Location Morrisville, NC
Product Type Devices
Quantity 5530 units

Product Description

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 for Recall

The firm received reports indicating PTD tip separation during use.

Distribution Pattern

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.

Lot / Code Information

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

Other Recalls from TELEFLEX MEDICAL INC

Recall # Classification Product Date
Z-1126-2022 Class II (1) Gibeck Humid-Vent 2S Flex DC, Product #1773... Apr 11, 2022
Z-1127-2022 Class II (1) Teleflex Flex tube, Product #20011, sterile... Apr 11, 2022
Z-0629-2022 Class I Arrow-Trerotola PTD Set (Percutaneous Thromboly... Jan 11, 2022
Z-0625-2022 Class I Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... Jan 11, 2022
Z-0623-2022 Class I Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... Jan 11, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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