HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
FDA device recall Z-1196-2017 · posted 2017-02-13 · Terminated
Recall details
- Recalling firm
- Argon Medical Devices, Inc
- Reason for recall
- The recalling firm received a complaint from one of their customers of a 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
- Argon Medical Devices, Inc. is sending an Urgent Product Recall Notice letter dated January 17, 2017, by registered mail to all affected customers. Customers were asked to determine if their inventory shows the package defect and discontinue use of the device and promptly return the affected product. For questions regarding this recall call 903-403-0749.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 15 boxes
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Switzerland, Canada, Australia, New Zealand, Ecuador, Colombia, and Japan.
- Date initiated
- 2017-01-18
- Date posted
- 2017-02-13
- Date terminated
- 2017-05-17
- Location
- Athens, TX
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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 |