Home / Recalls / Mermaid Medical A/S / Z-2190-2015

Z-2190-2015 Class II Terminated

Recalled by Mermaid Medical A/S — Stenl?se, N/A

Recall Details

Product Type: Devices
Report Date: July 29, 2015
Initiation Date: June 15, 2015
Termination Date: December 7, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 320

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.

Distribution Pattern

US Distribution to FL including PR.

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)