Medtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc., Minneapolis, MN 55432-5804
FDA device recall Z-0477-2008 · posted 2008-01-26 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin
- Action taken
- Medtronic sales force was notified and initiated calls with cutomers on 10/1/07. Additionally, certified Urgent Medical Device Recall letters dated 10/5/2007, were sent to the 32 customers. The letter explained the situaiton and requested that the impacted product be returned for replacement or credit. Medtronic is assessing patient use risks and will report those when determined. Standard post-surgical monitoring is advised at the present by Medtronic .
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DTN
- Quantity affected
- 413
- Distribution
- Nationwide including the states of IL, CT, OK, OH, MN, FL, NY, KS, MO, LA, PA, IN, CA, MI, KY, SC, NE, and AR.
- Date initiated
- 2007-10-01
- Date posted
- 2008-01-26
- Date terminated
- 2008-10-23
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EL2-SERIES BLOOD COLLECTION REERVOIR (K930154) | Electromedics, Inc. | 1993-07-01 |