T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can
FDA device recall Z-2189-2015 · posted 2015-07-21 · Terminated
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- Reason for recall
- Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
- Action taken
- The recalling firm's sales force was notified of the recall on 6/17/15. The recalling firm will begin to send out Urgent Medical Device Recall letters by registered mail to affected customers on 6/18/15. Customers are instructed to inspect and quarantine and return any affected product and complete the Recal Response Form.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 10290 units
- Distribution
- US
- Date initiated
- 2015-06-18
- Date posted
- 2015-07-21
- Date terminated
- 2016-06-23
- Location
- Athens, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MD TECH BIOPSY SET FOR BONE AND BONE MARROW (K980196) | Medical Device Technologies, Inc. | 1998-02-03 |