Reported Feb 23, 2022 · Terminated
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The…
Teleflex Medical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TELEFLEX MEDICAL INC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
- Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device)
- PT-45509 containing componentsPT-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
- Lot codes and dates
90 of 90 products
Products covered by this recall # Barcodes Product as published 1 Lot number 14C19F1336; Code PT-45509-S6 2 Lot number 14C19J0340; Code PT-45509-T 3 Lot number 13C19L1173; Code PT-45509-T 4 Lot number 13C19M0193 5 10801902121261Lot Number / UDI: 13F20B0054 / (01)10801902121261(17)220131(10)13F20B0054, Components: Code PT-45509-S6 6 Lot number 14C19F1336; Code PT-45509-S6 7 Lot number 14C19J0340; Code PT-45509-S6 8 Lot number 14C20A0602; Code PT-45509-T 9 Lot number 13C19L1173; Code PT-45509-T 10 Lot number 13C20A1583; Code PT-45509-T 11 Lot number 13C19M0193 12 10801902121261Lot Number / UDI: 13F20B0527 / (01)10801902121261(17)220228(10)13F20B0527, Components: Code PT-45509-T 13 Lot number 13C20A2409; Code PT-45509-S6 14 Lot number 14C20A0602 15 10801902121261Lot Number / UDI: 13F20C0427 / (01)10801902121261(17)220228(10)13F20C0427, Components: Code PT-45509-S6 16 Lot number 14C20A0602; Code PT-45509-T 17 Lot number 13C20A2409; Code PT-45509-T 18 Lot number 13C20A2409; Code PT-45509-T 19 Lot number 13C20C0842 20 10801902121261Lot Number / UDI: 13F20D0127 / (01)10801902121261(17)220331(10)13F20D0127, Components: Code PT-45509-S6 - Amount recalled
- 3668 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Stop using this product now
The firm received reports indicating PTD tip separation during use.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Teleflex Medical Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.