| Date Initiated by Firm | April 18, 2007 |
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| Date Posted | July 26, 2007 |
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| Recall Status1 |
Terminated 3 on November 01, 2007 |
| Recall Number | Z-1110-2007 |
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| Recall Event ID |
37273 |
| 510(K)Number | K926226 |
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| Product Classification |
Cardiotomy Reservoir - Product Code DTZ
|
| Product | Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer: Medtronic, Inc., Minneapolis, MN |
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| Code Information |
Lot 7192800 |
Recalling Firm/
Manufacturer |
Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
|
Manufacturer 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. |
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FDA Determined
Cause 2 | Other |
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| Action | 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. |
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| Quantity in Commerce | 11 units |
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| Distribution | Nationwide: Distributed to states of CO and PA |
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| Total Product Life Cycle | TPLC Device Report |
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|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = DTZ
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