FDAFDA · Food and drugs·Recall number Z-0625-2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C 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.
Published February 23, 2022 · Recall initiated: January 11, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm received reports indicating PTD tip separation during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- TELEFLEX MEDICAL INC
- Distributor
- 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
- Lot Number / UDI: 13F19M0129 / (01)10801902121315 (17)211130 (10)13F19M0129, Components: Code PT-65709-C, Lot number 13C19M0499; Lot Number / UDI: 13F20B0053 / (01)108019022121315 (17)220131 (10)13F20B0053, Components: Code PT-65709-C, Lot number 13C20A0970; Lot Number / UDI: 13F20C0595 / (01)10801902121315 (17)220331 (10)13F20C0595, Components: Code PT-65709-C, Lot number 13C20C2089; Code PT-65709-C, Lot number 13C20C2082; Lot Number / UDI: 13F20F0231 / (01)10801902121315 (17)220531 (10)13F20F0231, Components: Code PT-65709-C, Lot number 13C20F1139; Lot Number / UDI: 13F20G0361 / (01)10801902121315 (17)220731 (10)13F20G0361, Components: Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-C, Lot number 13C20G0228; Lot Number / UDI: 13F20K0632 / (01)10801902121315 (17)221031 (10)13F20K0632, Components: Code PT-65709-C, Lot number 13C20H1675; Lot Number / UDI: 13F21A0353 / (01)10801902121315 (17)221231 (10)13F21A0353, Components: Code PT-65709-C, Lot number 13C20M0639; Code PT-65709-C, Lot number 13C20J2689; Lot Number / UDI: 13F21C0748 / (01)10801902121315 (17)230331 (10)13F21C0748, Components: Code PT-65709-C, Lot number 13C21C1696; Lot Number / UDI: 13F21D0721 / (01)10801902121315 (17)230430 (10)13F21D0721, Components: Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-C, Lot number 13C21C2412; Code PT-65709-C, Lot number 13C21C0326; Lot Number / UDI: 13F21E0823 / (01)10801902121315 (17)230531 (10)13F21E0823, Components: Code PT-65709-C, Lot number 13C21E0328; Lot Number / UDI: 13F21F1189 / (01)10801902121315 (17)230630 (01)13F21F1189, Components: Code PT-65709-C, Lot number 13C21E1991; Code PT-65709-C, Lot number 13C21E0328
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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