Z-2190-2015Class II

Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only...

Name: Z-2190-2015 Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only...
Creator: Mermaid Medical A/S
Published: 2015-06-15
License: https://open.fda.gov/license/

Mermaid Medical A/S / initiated 2015-06-15 / Terminated / root cause: manufacturing process

FDA source

Mermaid Medical A/S began a recall of 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... on 2015-06-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2190-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-15
Posted: 2015-07-22
Terminated: 2015-12-07
Recalling firm: Mermaid Medical A/S
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.
Product code: DWO Needle, Biopsy, Cardiovascular
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Mermaid Medical, notified both customers directly via email with written letters dated June 12 and June 15, 2015 followed up by sales and customer service for product return to MMI. The customers were instructed to "Please coordinate the return of the mentioned products with corresponding lot numbers with our Mermaid Medical's Customer Care the recalled product: either by phone at 1{720}420-9999 or by email: [email protected]". If you have any questions please do not hesitate to contact Vice President QA & Regulatory Affairs toll free at (855) 427-6799 or (720) 420-9999 or email: [email protected].
Quantity in commerce: 320
Distribution: US Distribution to FL including PR.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2190-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2190-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22

Product code DWO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)