Device 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.
Z-2190-2015
Product summary
- Event
- Event 71525
- Status
- Terminated
- Classification
- Class II
- Quantity
- 320
- Official record key
device-enforcement:Z-2190-2015
Official wording
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.
Code information: Lot No: P000290, P000360, P000230, P000291, P000299, P000148 Catalogue No: N20314010- N20320020 (for PRO-MAG Biopsy Instrument) Catalogue No: N20414010- N20420020 (for MAGNUM Biopsy Instrument)
Distribution pattern: US Distribution to FL including PR.
Derived failure modes
-
Foreign material or chemical contamination
plastic pieces