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Harvest
M.D.L. S.R.L. · Model PJE1110 · UDI-DI 08056138586000
DWO
Prescription
10
510(k) clearances
103
Adverse events
9
Recalls
45
Facilities
Description
DISPOSABLE BIOPSY NEEDLE FOR BONE MARROW TRANSPLANTATION WITH "T" HANDLE 11G X 100 mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-08-05 | M.D.L. S.r.l. | Sterility assurance may be compromised. |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | 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 |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | 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 |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | 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 |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | 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 |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | 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 |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | 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 |
| 2018-12-18 | Angiotech (Manan Medical Products, Inc.) | 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 |
| 2015-06-15 | Mermaid Medical A/S | Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer of the cannula. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.