Reported Jul 29, 2015 · Terminated
Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single…
Mermaid Medical A/S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mermaid Medical A/S · Frydensbergvej 25 · Stenl?se, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Lot No
P000290P000360P000230P000291P000299
- P000148 Catalogue NoN20314010- N20320020 (for
- PRO-MAG Biopsy Instrument) Catalogue NoN20414010- N20420020 (for MAGNUM Biopsy Instrument)
- Lot No
- Amount recalled
- 320
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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