Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer: Medtronic, Inc., Mi
FDA device recall Z-1110-2007 · posted 2007-07-26 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Pyrogen Levels detected above specification: The product contains a pyrogen level above Medtronic''s internal specifications while the product is labeled as nonpyrogenic.
- Action taken
- The consignees were notified by personal contact and requested to stop using the devices in question. A customer letter (April 24, 2007) will be sent by e-mail which explains the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a Recall Certificate acknowledging the receipt of this information.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 11 units
- Distribution
- Nationwide: Distributed to states of CO and PA
- Date initiated
- 2007-04-18
- Date posted
- 2007-07-26
- Date terminated
- 2007-11-01
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTERSEPT FILTERED CARDIOTOMY RESERVOIR (K926226) | Medtronic Vascular | 1993-06-22 |