Recall Z-2190-2015— Mermaid Medical A/S
Class II · Terminated
Class II FDA medical device recall by Mermaid Medical A/S, initiated 2015-06-15, terminated 2015-12-07. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Mermaid Medical A/S
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-15
- Terminated
- 2015-12-07
- Firm location
- Stenl?se, N/A, Denmark
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.