Mermaid Medical M-Biopsy Coaxial Introducer Needle recalled over possible plastic fragments

Recall date

June 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Mermaid Medical A/S recalls Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packe…

Recall number

Z-2190-2015

FDA classification

Class II

Brand / firm

Mermaid Medical A/S

Sold / distributed

US Distribution to FL including PR.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.