ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable
FDA device recall Z-0597-2007 · posted 2007-03-08 · Terminated
Recall details
- Recalling firm
- Kensey Nash Corp
- Reason for recall
- Face seal may wear excessively and cause particulate matter.
- Action taken
- On 2/7/07, a voice mail message was sent to all KNC Sales Representatives instructing them to contact affected accounts immediately. On 2/9/07, recall notices were faxed to all affected accounts that had affected product. The recall notices instructed hospitals to quarantine the affected lots and to contact their KNC Sales Representative to arrange for retrieval of the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 165 units
- Distribution
- Nationwide.
- Date initiated
- 2007-02-07
- Date posted
- 2007-03-08
- Date terminated
- 2007-06-12
- Location
- Exton, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THROMCAT THROMBECTOMY CATHETER SYSTEM (K060016) | Kensey Nash Corp. | 2006-04-25 |