Reported Feb 8, 2023 · Ongoing
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE…
Medtronic Perfusion Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
- Lot codes and dates
- Model BB841
- Serial Number Range8111483548 - 8113999999
- GTIN Number00643169354869 (Lot
- Numbers
163 of 163 codes
133846371338515213385470133857451338598113386194133863351338674713386941133870681338724713387298133874831338767013387792133880081338822713389074133893051338982313389827133900101339033013390505133905161339075113391244133912641339156413392146133922531339272713393000133930361339358313393871133942401339437013394371133944241339464213394972133950231339580313395855133959241339614113396262223431961223431962223476434223476435223525108223525109223525110223662140223662141223662142223662143223662144
- GTIN Number00643169354883 (Lot
- Numbers
202 of 202 codes
13384723133847301338488113384976133855831338576713385867133862281338647813388449133884521338854413388598133891911338959813389870133901681339064013390684133908741339098413391365133913901339166313391937133922211339246413392614133929031339297513393065133931761339334213393342133936581339389013393921133940291339415113394821133953301339533213395410133954611339552413395771223388884223392415223392423223392435223431964223431965223431986223476436223476437223476438223476439223476439223476440223523220
- GTIN Number00643169588660(Lot
- Numbers
1338598113387247133874831338779213389305133898231338982713390516133907511339124413391564133943701339442413395924223476434223662140223662144223961794224087129224401622224526860224772929225020112225090559225162245225162946)
- Amount recalled
- 90,220 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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