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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89390

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 11, 2022
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
TELEFLEX MEDICAL INC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-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.

Z-0623-2022
Recall number
Z-0623-2022
Initiated
January 11, 2022
Classification
Class I
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
676 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received reports indicating PTD tip separation during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received reports indicating PTD tip separation during use.

Code information

Lot Number / UDI: 13F19K0564 / (01)20801902156758 (17)210930 (10)13F19K0564, Components: Code PT-12709-CA, Lot number 13C19K2024; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C19J1873; Lot Number / UDI: 13F20C0094 / (01)10801902121254 (17)220228 (10)13F20C0094, Components: Code PT-12709-C, Lot number 13C20C0498; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C19M0278; Code PT-03009, Lot number 13C19J1873; Lot Number / UDI: 13F20G0284 / (01)10801902121254 (17)220630 (10)13F20G0284, Components: Code PT-12709-C, Lot number 13C20G0230; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20G0238; Code PT-03009, Lot number 13C20F2585; Lot Number / UDI: 13F20L0282 / (01)10801902121254 (17)221031 (10)13F20L0282, Components: Code PT-12709-C, Lot number 13C20J0307; Code PT-65709-HS, Lot number 14C20H0384; Code PT-03009, Lot number 13C20L0872; Lot Number / UDI 13F21A0497 / (01)10801902121254 (17)221231 (10)13F21A0497, Components: Code PT-12709-C, Lot number 13C20J0307; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20M0144; Lot Number / UDI: 13F21A0718 / (01)10801902121254 (17)230131 (10)13F21A0718, Components: Code PT-12709-C, Lot number 13C21A1963; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21A0855; Code PT-03009, Lot number 13C20M0144; Lot Number / UDI: 13X21E0008 / (01)10801902121254 (17)230630 (10)13F21F1187, Components: Code PT-12709-C, Lot number 13C21C1690; Code PT-65709-HS, Lot number 14C21D0635; Code PT-65709-HS, Lot number 14C21C0476; Code PT-03009, Lot number 13C21C2413; Lot Number / UDI: 13F21F1187 / (01)10801902121254 (17)230531 (10)13X21E0008, Components: Code PT-12709-C, Lot number 13X21E0009; Code PT-65709-HS, Lot number 14X21D0002; Code PT-03009, Lot number 13X21E0007

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.

device · product 2 of 7

Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS 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.

Z-0624-2022
Recall number
Z-0624-2022
Initiated
January 11, 2022
Classification
Class I
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
1400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received reports indicating PTD tip separation during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received reports indicating PTD tip separation during use.

Code information

Lot Number / UDI: 13F20A0323 / (01)108019022121292 (17)211231 (10)13F20A0323, Components: Code PT-65709-C, Lot number 13C19M0499; Code PT-65709-HFS, Lot number 14C19J0342; Code PT-03009, Lot number 13C19J1873; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C19J0572; Code PT-03009, Lot number 13C19K0832; Lot Number / UDI: 13F20B0139 / (01)10801902121292 (17)220131 (10)13F20B0139, Components: Code PT-65709-C, Lot number 13C20A0970; Code PT-65709-HFS, Lot number 14C20A0611; Code PT-65709-HFS, Lot number 14C19G0671; Code PT-03009, Lot number 13C19L0622; Lot Number / UDI: 13F20C0594 / (01)10801902121292 (17)220331 (10)13F20C0594, Components: Code PT-65709-C, Lot number 13C20C2082; Code PT-65709-HFS, Lot number 14C20A0611; Code PT-65709-HFS, Lot number 14C19J0342; Code PT-03009, Lot number 13C20B1435; Lot Number / UDI: 13F20F008 3/ (01)10801902121292 (17)220531 (10)13F20F0083, Components: Code PT-65709-C, Lot number 13C20F0572; Code PT-65709-HFS, Lot number 14C20D1060; Code PT-65709-HFS, Lot number 14C20A0611; Code PT-03009, Lot number 13C20C1558; Code PT-03009, Lot number 13C20B1435; Lot Number / UDI: 13F20F0230 / (01)10801902121292 (17)220531 (10)13F20F0230, Components: Code PT-65709-C, Lot number 13C20F1139; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-65709-HFS, Lot number 14C20D1060; Code PT-03009, Lot number 13C20F0570; Lot Number / UDI: 13F20F0577 / (01)10801902121292 (17)220630 (10)13F20F0577, Components: Code PT-65709-C, Lot number 13C20F2175; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-03009, Lot number 13C20F1138; Code PT-03009, Lot number 13C20F0570; Lot Number / UDI: 13F20H0756 / (01)10801902121292 (17)220831 (10)13F20H0756, Components: Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-HFS, Lot number 14C20F0274; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-03009, Lot number 13C20H0604; Code PT-03009, Lot number 13C20G1198; Lot Number / UDI: 13F20K0849 / (01)10801902121292 (17)221031 (10)13F20K0849, Components: Code PT-65709-C, Lot number 13C20H1675; Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-65709-HFS, Lot number 14C20F0274; Code PT-03009, Lot number 13C20H0604; Lot Number / UDI: 13F20L0283 / (01)10801902121292 (17)221031 (10)13F20L0283, Components: Code PT-65709-C, Lot number 13C20H1675; Code PT-65709-C, Lot number 13C20J2689; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-03009, Lot number 13C20L0872; Lot Number / UDI: 13F20M0182 / (01)10801902121292 (17)221231 (10)13F20M0182, Components: Code PT-65709-C, Lot number 13C20J2689; Code PT-65709-C, Lot number 13C20H1675; Code PT-65709-HFS, Lot number 14C20L0665; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-03009, Lot number 13C20L0871; Lot Number / UDI: 13F21A0498 / (01)10801902121292 (17)221231 (10)13F21A0498, Components: Code PT-65709-C, Lot number 13C20M0639; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-03009, Lot number 13C21A0855; Lot Number / UDI: 13F21B0158 / (01)10801902121292 (17)230131 (10)13F21B0158, Components: Code PT-65709-C, Lot number 13C21A1348; Code PT-65709-HFS, Lot number 14C20M0932; Code PT-65709-HFS, Lot number 14C20L0665; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-03009, Lot number 13C21A0855; Lot Number / UDI: 13F21C0747 / (01)10801902121292 (17)230331 (10)13F21C0747, Components: Code PT-65709-C, Lot number 13C21C0326; Code PT-65709-C, Lot number 13C21A1348; Code PT-65709-HFS, Lot number 14C20L0665; Code PT-65709-HFS, Lot number 14C20M0932; Code PT-03009, Lot number 13C21B1533; Lot Number / UDI: 13F21E0555 / (01)108019021212292 (17)230430 (10)13F21E0555, Components: Code PT-65709-C, Lot number 13C21E0328; Code PT-65709-C, Lot number 13C21D0717; Code PT-65709-C, Lot number 13C21C2412; Code PT-65709-HFS, Lot number 14C21C0895; Code PT-65709-HFS, Lot number 14C20M0932; Code PT-03009, Lot number 13C21C2413; Code PT-03009, Lot number 13C21C2397

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.

device · product 3 of 7

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.

Z-0625-2022
Recall number
Z-0625-2022
Initiated
January 11, 2022
Classification
Class I
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
1265 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received reports indicating PTD tip separation during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received reports indicating PTD tip separation during use.

Code information

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

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.

device · product 4 of 7

Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS 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.

Z-0626-2022
Recall number
Z-0626-2022
Initiated
January 11, 2022
Classification
Class I
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
1874 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received reports indicating PTD tip separation during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received reports indicating PTD tip separation during use.

Code information

Lot Number / UDI: 13F20C0596 / (01)10801902121308 (17)220331 (10)13F20C0596, Components: Code PT-65709-C, Lot number 13C20C2082; Code PT-65709-HS, Lot number 14C20C1417; Code PT-03009, Lot number 13C20B1435; Code PT-03009, Lot number 13C19M0278; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C20C1558; Lot Number / UDI: 13F20F0081 / (01)10801902121308 (17)220531 (10)13F20F0081, Components: Code PT-65709-C, Lot number 13C20F0572; Code PT-65709-C, Lot number 13C20C2082; Code PT-65709-HS, Lot number 14C20C0866; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C20C1558; Lot Number / UDI: 13F20F0229 / (01)10801902121308 (17)220531 (10)13F20F0229, Components: Code PT-65709-C, Lot number 13C20F0572; Code PT-65709-HS, Lot number 14C20C0866; Code PT-03009, Lot number 13C20F0570; Code PT-03009, Lot number 13C20C1558; Lot Number / UDI: 13F20F0509 / (01)10801902121308 (17)220531 (10)13F20F0509, Components: Code PT-65709-C, Lot number 13C20F1139; Code PT-65709-HS, Lot number 14C20C0866; Code PT-65709-HS, Lot number 14C20C1417; Code PT-03009, Lot number 13C20F0570; Lot Number / UDI: 13F20F0578 / (01)10801902121308 (17)220630 (10)13F20F0578, Components: Code PT-65709-C, Lot number 13C20F2175; Code PT-65709-HS, Lot number 14C20D1061; Code PT-65709-HS, Lot number 14C20C0866; Code PT-03009, Lot number 13C20F2585; Code PT-03009, Lot number 13C20F1138; Lot Number / UDI: 13F20G0177 / (01)10801902121308 (17)220630 (10)13F20G0177, Components: Code PT-65709-C, Lot number 13C20G0228; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20F2585; Code PT-03009, Lot number 13C20G0238 Lot Number / UDI: 13F20G0566 / (01)10801902121308 (17)220630 (10)13F20G0566, Components: Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20G0864; Code PT-03009, Lot number 13C20G0238; Code PT-03009, Lot number 13C20F2585; Lot Number / UDI: 13F20H0531 / (01)10801902121308 (17)220831 (10)13F20H0531, Components: Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-HS, Lot number 14C20G0395; Code PT-03009, Lot number 13C20G1198; Code PT-03009, Lot number 13C20G0864; Lot Number / UDI: 13F20J0379 / (01)10801902121308 (17)220831 (10)13F20J0379, Components: Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-C, Lot number 13C20G1199; Code PT-65709-HS, Lot number 14C20H0384; Code PT-03009, Lot number 13C20H0604; Lot Number / UDI: 13F20L0514 / (01)10801902121308 (17)221031 (10)13F20L0514, Components: Code PT-65709-C, Lot number 13C20J2689; Code PT-65709-HS, Lot number 14C20H0384; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20L0871; Code PT-03009, Lot number 13C20L0872; Lot Number / UDI: 13F21A0354 / (01)10801902121308 (17)221231 (10)13F21A0354, Components: Code PT-65709-C, Lot number 13C20M0639; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20M0144; Lot Number / UDI: 13F21C0081 / (01)10801902121308 (17)230228 (10)13F21C0081, Components: Code PT-65709-C, Lot number 13C21A1348; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21B1533; Code PT-03009, Lot number 13C21A0855; Lot Number / UDI: 13F21C0749 / (01)10801902121308 (17)230331 (10)13F21C0749, Components: Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-HS, Lot number 14C21B0690; Code PT-65709-HS, Lot number 13C21C1696; Code PT-03009, Lot number 13C21C0327; Code PT-03009, Lot number 13C21B1533; Lot Number / UDI: 13F21D0870 / (01)10801902121308 (17)230430 (10)13F21D0870, Components: Code PT-65709-C, Lot number 13C21D0717; Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-HS, Lot number 14C21B0690; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21C0327; Lot Number / UDI: 13F21E0415 / (01)10801902121308 (17)230430 (10)13F21E0415, Components: Code PT-65709-C, Lot number 13C21C2412; Code PT-65709-C, Lot number 13C21D0717; Code PT-65709-C, Lot number 13C21C1696; Code PT-65709-HS, Lot number 14C21C0476; Code PT-65709-HS, Lot number 14C21B0690; Code PT-03009, Lot number 13C21C2397; Code PT-03009, Lot number 13C21C2413; Code PT-03009, Lot number 13C21C0327; Code PT-03009, Lot number 13C21B1533; Lot Number / UDI: 13F21F1188 / (01)10801902121308 (17)230630 (10)13F21F1188, Components: Code PT-65709-C, Lot number 13C21E0328; Code PT-65709-C, Lot number 13C21E1991; Code PT-65709-HS, Lot number 14C21D0635; Code PT-65709-HS, Lot number 14C21C0476; Code PT-03009, Lot number 13C21C2413; Code PT-03009, Lot number 13C21E0722

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.

device · product 5 of 7

Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T 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.

Z-0627-2022
Recall number
Z-0627-2022
Initiated
January 11, 2022
Classification
Class I
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
3668 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received reports indicating PTD tip separation during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received reports indicating PTD tip separation during use.

Code information

Lot Number / UDI: 13F20A0209 / (01)10801902121261(17)211231(10)13F20A0209, Components: Code PT-45509-S6, Lot number 14C19F1336; Code PT-45509-S6, Lot number 14C19J0340; Code PT-45509-T, Lot number 13C19L1173; Code PT-45509-T, Lot number 13C19M0193; Lot Number / UDI: 13F20B0054 / (01)10801902121261(17)220131(10)13F20B0054, Components: Code PT-45509-S6, Lot number 14C19F1336; Code PT-45509-S6, Lot number 14C19J0340; Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-T, Lot number 13C19L1173; Code PT-45509-T, Lot number 13C20A1583; Code PT-45509-T, Lot number 13C19M0193; Lot Number / UDI: 13F20B0527 / (01)10801902121261(17)220228(10)13F20B0527, Components: Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-S6, Lot number 14C20A0602; Lot Number / UDI: 13F20C0427 / (01)10801902121261(17)220228(10)13F20C0427, Components: Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-T, Lot number 13C20C0842; Lot Number / UDI: 13F20D0127 / (01)10801902121261(17)220331(10)13F20D0127, Components: Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-S6, Lot number 14C20C1054; Code PT-45509-T, Lot number 13C20D0847; Lot Number / UDI: 13F20D0402 / (01)10801902121261(17)220430(10)13F20D0402, Components: Code PT-45509-S6, Lot number 14C20C1054; Code PT-45509-S6, Lot number 14C20D0569; Code PT-45509-T, Lot number 13C20D2088; Lot Number / UDI: 13F20F0390 / (01)10801902121261(17)220531(10)13F20F0390, Components: Code PT-45509-S6, Lot number 14C20C1054; Code PT-45509-S6, Lot number 14C20D0569; Code PT-45509-T, Lot number 13C20E0902; Lot Number / UDI: 13F20G0285 / (01)10801902121261(17)220630(10)13F20G0285, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-S6, Lot number PT-45509-T; Code 13C20G0868, Lot Number / UDI: 13F20J0545 / (01)10801902121261(17)220831(10)13F20J0545, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-T, Lot number 13C20G1979; Lot Number / UDI: 13F20J0933 / (01)10801902121261(17)220930(10)13F20J0933, Components: Code PT-45509-S6, Lot number 14C20J1445; Code PT-45509-T, Lot number 13C20G1979; Code PT-45509-T, Lot number 13C20J1577; Lot Number / UDI: 13F20K0851 / (01)10801902121261(17)221031(10)13F20K0851, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-S6, Lot number 14C20J1445; Code PT-45509-T, Lot number 13C20G1979; Code PT-45509-T, Lot number 13C20J1577; Lot Number / UDI: 13F20M0174 / (01)10801902121261(17)221120(10)13F20M0174, Components: Code PT-45509-S6, Lot number 14C20K1177; Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-T, Lot number 13C20K1686; Code PT-45509-T, Lot number 13C20L1807; Lot Number / UDI: 13F21A0662 / (01)10801902121261(17)230131(10)13F21A0662, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-S6, Lot number 14C21A0480; Code PT-45509-T, Lot number 13C20K1686; Code PT-45509-T, Lot number 13C20L1807; Lot Number / UDI: 13F21C0079 / (01)10801902121261(17)230228(10)13F21C0079, Components: Code PT-45509-S6, Lot number 14C21A0480; Code PT-45509-T, Lot number 13C20J0354; Lot Number / UDI: 13F21C0751 / (01)10801902121261(17)230331(10)13F21C0751, Components: Code PT-45509-S6, Lot number 14C21A0480; Code PT-45509-S6, Lot number 14C21B0676; Code PT-45509-S6, Lot number 14C21C0477; Code PT-45509-T, Lot number 13C21C1697; Code PT-45509-T, Lot number 13C21B0771; Lot Number / UDI: 13X21D0027 / (01)10801902121261(17)230430(10)13X21D0027, Components: Code PT-45509-S6, Lot number 14X21D0003; Code PT-45509-S6, Lot number 14C21B0676; Code PT-45509-T, Lot number 13X21D0009; Lot Number / UDI: 13F21F0399 / (01)10801902121261(17)230531(10)13F21F0399, Components: Code PT-45509-S6, Lot number 14C21C0477; Code PT-45509-S6, Lot number 14C21D0675; Code PT-45509-T, Lot number 13C21E0717; Lot Number / UDI: 13F21G0226 / (01)10801902121261(17)230630(10)13F21G0226, Components: Code PT-45509-S6, Lot number 14C21C0477; Code PT-45509-S6, Lot number 14C21E0925; Code PT-45509-T, Lot number 13C21F2205; Lot Number / UDI: 13F21G1343 / (01)10801902121261(17)230731(10)13F21G1343, Components: Code PT-45509-S6, Lot number 14C21E0925; Code PT-45509-T, Lot number 13C21F2205; Lot Number / UDI: 13F21H0639 / (01)10801902121261(17)230731(10)13F21H0639, Components: Code PT-45509-S6, Lot number 14C21E0925; Code PT-45509-S6, Lot number 14C21G1307; Code PT-45509-T, Lot number 13C21H0942; Lot Number / UDI: 13F21H1272 / (01)10801902194067(17)230831(10)13F21H1272, Components: Code PT-45509-T2, Lot number 13C21H2037; Code PT-45509-S7, Lot number 14C21H0978; Lot Number / UDI: 13F21L0900 / (01)10801902194067(17)231130(10)13f21l0900, Components: Code PT-45509-T2, Lot number 13C21L1103; Code PT-45509-S7, Lot number 14C21H1310

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.

device · product 6 of 7

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.

Z-0628-2022
Recall number
Z-0628-2022
Initiated
January 11, 2022
Classification
Class I
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
5530 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received reports indicating PTD tip separation during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received reports indicating PTD tip separation during use.

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

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.

device · product 7 of 7

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 dialysis grafts.

Z-0629-2022
Recall number
Z-0629-2022
Initiated
January 11, 2022
Classification
Class I
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
14583 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm received reports indicating PTD tip separation during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm received reports indicating PTD tip separation during use.

Code information

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; Lot Number / UDI: 13F20J0546 / (01)00801902013156(17)220831(10)13F20J0546; Lot Number / UDI: 13F20J0771 / (01)00801902013156(17)220831(10)13F20J0771; Lot Number / UDI: 13F20K0503 / (01)00801902013156(17)220930(10)13F20K0503; Lot Number / UDI: 13F20K0504 / (01)00801902013156(17)220930(10)13F20K0504; Lot Number / UDI: 13F20K0630 / (01)00801902013156(17)220930(10)13F20K0630; Lot Number / UDI: 13F20K0631 / (01)00801902013156(17)220930(10)13F20K0631; Lot Number / UDI: 13F20M0175 / (01)00801902013156(17)221130(10)13F20M0175; Lot Number / UDI: 13F20M0176 / (01)00801902013156(17)221130(10)13F20M0176; Lot Number / UDI: 13F20M0177 / (01)00801902013156(17)221130(10)13F20M0177; Lot Number / UDI: 13F20M0178 / (01)10801902013153(17)221130(10)13F20M0178; Lot Number / UDI: 13F20M0181 / (01)00801902013156(17)221231(10)13F20M0181; Lot Number / UDI: 13F21A0352 / (01)00801902013156(17)221231(10)13F21A0352; Lot Number / UDI: 13F21B0159 / (01)00801902013156(17)230131(10)13F21B0159; Lot Number / UDI: 13F21B0222 / (01)00801902013156(17)230131(10)13F21B0222; Lot Number / UDI: 13F21B0519 / (01)10801902013153(17)230228(10)13F21B0519; Lot Number / UDI: 13F21C0364 / (01)00801902013156(17)230228(10)13F21C0364; Lot Number / UDI: 13F21C0365 / (01)00801902013156(17)230228(10)13F21C0365; Lot Number / UDI: 13F21D0462 / (01)00801902013156(17)230331(10)13F21D0462; Lot Number / UDI: 13F21E0079 / (01)00801902013156(17)230430(10)13F21E0079; Lot Number / UDI: 13F21E0259 / (01)00801902013156(17)230430(10)13F21E0259; Lot Number / UDI: 13F21E0260 / (01)00801902013156(17)230430(10)13F21E0260; Lot Number / UDI: 13F21E0556 / (01)00801902013156(17)230430(10)13F21E0556; Lot Number / UDI: 13F21F0641 / (01)00801902013156(17)230531(10)13F21F0641; Lot Number / UDI: 13F21G0227 / (01)00801902013156(17)230630(10)13F21G0227; Lot Number / UDI: 13F21G0401 / (01)00801902013156(17)230630(10)13F21G0401; Lot Number / UDI: 13F21G0772 / (01)00801902013156(17)230630(10)13F21G0772; Lot Number / UDI: 13F21H0447 / (01)10801902194074(17)230731(10)13F21H0447; Lot Number / UDI: 13F21K0827 / (01)10801902194074(17)231031(10)13F21K0827; Lot Number / UDI: 13F21K0898 / (01)10801902194074(17)231031(10)13F21K0898; Lot Number / UDI: 13F21L0227 / (01)20801902194071(17)231031(10)13F21L0227; Lot Number / UDI: 13F21L0507 / (01)10801902194074(17)231031(10)13F21L0507; Lot Number / UDI: 13F21L0898 / (01)10801902194074(17)231031(10)13F21L0898

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.