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

FDA device recall Z-2190-2015 · posted 2015-07-22 · Terminated

Recall details

Recalling firm

Mermaid Medical A/S

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.

Action taken

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: customercare@mermaidmedical.com". 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: customercare@memaidmedical.com.

Root cause

Process control

Status

Terminated

Product code

DWO

Quantity affected

320

Distribution

US Distribution to FL including PR.

Date initiated

2015-06-15

Date posted

2015-07-22

Date terminated

2015-12-07

Location

se, Denmark