Reported Dec 17, 2014 · Terminated
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use,…
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?
- The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is non-toxic, nonpyrogenic, and supplied sterile in individual packaging.
- Lot codes and dates
- Lot number 12981001
- with the following Serial Numbers
80 of 80 codes
811013805581101411558110141281811014145981101380568110141162811014130481101414698110138061811014116781101413058110141471811013809681101411688110141315811014149781101393068110141182811014132081101415188110139330811014118481101413318110141527811013985681101411888110141335811014153381101408198110141193811014134281101415878110140824811014121581101413688110141604811014098581101412198110141380811014160581101410458110141222811014139181101416138110141082811014123081101414038110141616811014108381101412388110141415811014162181101411148110141240811014141681101417058110141119811014124481101414188110141731
- UPDATEDLot # 13011880, 13 (serial # 8110141520), 13023057 (Serial # 8110141435 and 8110141539)
- Amount recalled
- 66, UPDATE: 168 additional devices.
Where it was sold
Why it was recalled
Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold stand alone or incorporated in Total Systems TS1614R1 and TS1595R7. UPDATED: Recall was updated to incorporate three additional lots affected.
This product could cause temporary or reversible health problems — stop using it.
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