Reported Apr 7, 2021 · Ongoing
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1,…
Medtronic Perfusion Systems
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 Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
- Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console
- Model Numbers560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures
- Lot codes and dates
- 560BC: GTIN 00885074539386
- Serial Numbers
560B100094560B100212560B100244560B100257560B100274560B100283560B100418560B100439560B100482 560BC1: GTIN 00613994450326
- Serial Numbers
560B100901560B101368 560BCS: GTIN 00613994258236
- Serial Numbers
560B100369560B100376560B100472560B100495560B100496 560BCS1:
- GTIN00613994450463
- Serial Numbers
560B100191560B100690560B100783560B100806560B100820560B100871560B100896560B101062560B101187560B101318560B101344560B101470560B101499560B101504560B101519560B101593560B101526 GTIN 00613994526052
- Serial Numbers
560B102610560B102725 GTIN 00643169201033
- Serial Numbers560B101838 GTIN 00643169201651
- Serial Numbers560B101834 GTIN 00643169315822
- Serial Numbers
560B100127560B101694560B101700560B101805560B101976560B101996560B102080560B102118560B102185560B102194560B102204560B102210560B102215560B102265560B102336560B102426560B102493560B102518560B102547560B102559560B102598560B102761560B102762560B102763560B102764560B102765560B102766 GTIN 00763000135447
- Serial Numbers
560B102711560B102717560B102718560B102720560B102721560B102722560B102723560B102724560B102726560B102727560B102730560B102731560B102732560B102733560B102734560B102735560B102736560B102737560B102738560B102739560B102740560B102741560B102742560B102743560B102745560B102746560B102747560B102748560B102750560B102751560B102752560B102754560B102755560B102756560B102757560B102758560B102760560B102767560B102768560B102769560B102770560B102771560B102772560B102773560B102774560B102775560B102776 GTIN 00763000159412
- Serial Numbers
560B102930560B102931560B102932560B102933560B102934 GTIN 00763000236526
- Serial Numbers
269 of 269 codes
560B102778560B102779560B102780560B102781560B102782560B102783560B102784560B102785560B102786560B102787560B102788560B102789560B102790560B102792560B102793560B102794560B102795560B102796560B102797560B102798560B102799560B102800560B102801560B102802560B102803560B102804560B102805560B102806560B102807560B102809560B102810560B102811560B102812560B102813560B102815560B102817560B102818560B102819560B102820560B102821560B102822560B102823560B102824560B102825560B102826560B102827560B102828560B102829560B102830560B102831560B102832560B102833560B102834560B102835560B102836560B102837560B102838560B102839560B102840560B102841
- Serial Numbers
560B102009560B102355560B102367
- Amount recalled
- 387 devices (93 US)
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.
Using this product could cause serious injury, illness or death — stop using it now.
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