FDA Device recall Z-0817-2019
Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
- FDA Device
- Class II
- terminated
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class II recall of Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm by Angiotech Manan Medical Products, citing argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0817-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-18 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Angiotech Manan Medical Products |
| Distribution | US |
Product
Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
Reason
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Identifiers
| code_info | Model Number BMNJ-MEC-1110, Lot Number LHT1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0817-2019%22
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