Reported Jun 23, 2021 · Terminated
Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire…
Medtronic Vascular
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: Medtronic Vascular · 35-37A Cherry Hill Drive · Danvers, MA · 01923-2565
Is this the product you have?
- Angiographic Guidewire ComponentModel
- Number107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are not defined as they are not intended for final use
- Lot codes and dates
- GTIN00673978284569, 20613994885306, 00673978284576, 00673978284620, 20613994885337,00673978284729, 20613994885399, 20613994994534. Serial Number/Lot Number
159 of 159 codes
GFRF0544GFTJ1064GFTJ2054GFWD3486GFAP4022GFAP4023GFAR1705GFAS0270GFAS0271GFAU2099GFAU2100GFAV2023GFAW0536GFAX0346GFAX0347GFAX0348GFAX0349GFAY0671GFAY0672GFAZ0120GFAZ0121GFBN0459GFBP1047GFBP1048GFBQ1629GFBQ1630GFBQ1631GFBW0577GFCV1818GFCX1086GFDP0187GFWE3973GFWE3974GFWF3611GFWG4429GFWG4430GFWG4432GFWH2553GFWI3563GFWK0060GFWK0061GFWK0062GFWL0066GFWL2778GFWL2780GFXB0138GFXB0141GFXB3088GFXB3089GFXB3090GFXC3702GFXC3703GFXD4073GFXD4074GFXF2023GFXF2024GFXF2025GFXG1318GFXG1320GFXH2124
- GTIN00673978284569, 20613994885306, 00673978284576, 00673978284620, 20613994885337,00673978284729, 20613994885399, 20613994994534. Serial Number/Lot Number
- Amount recalled
- 54,997 units
Where it was sold
Why it was recalled
Stop using this product now
The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.
Using this product could cause serious injury, illness or death — stop using it now.
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