Class II — Mermaid Medical A/S
| Recalling firm | Mermaid Medical |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument. |
| Quantity | 320 |
| Distribution | US Distribution to FL including PR. |
| Initiated | 2015-06-15 |
| Classified | 2015-07-22 |
| Terminated | 2015-12-07 |
| Recall number | Z-2190-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Mermaid Medical A/S (Z-2190-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71525/
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