Recalls / —
—#178256
Product
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
- FDA product code
- DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K952532
- Affected lot / code info
- UDI 20643169858835, Lot Numbers: 13316512
Why it was recalled
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Root cause (FDA determination)
Process control
Action the firm took
Beginning 14-Nov-2019, Medtronic initiated an immediate Urgent Medical Device Recall via verbal communication to one (1) customer that was shipped the affected product according to Medtronic records. The customer was asked to identify and quarantine any unused affected product. The immediate communication was followed by a written urgent medical device recall notification beginning on 26-Nov-2019 to communicate the issue to the one (1) customer that received affected product. The consignee was asked to confirm receipt of urgent medical device recall notification via a Customer Confirmation Certificate. Medtronic is seeking the return of the affected product.
Recalling firm
- Firm
- Medtronic Perfusion Systems
- Address
- 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088
Distribution
- Distribution pattern
- CA
Timeline
- Recall initiated
- 2019-11-14
- Terminated
- 2020-10-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #178256. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.