Date Initiated by Firm |
June 15, 2015 |
Date Posted |
July 22, 2015 |
Recall Status1 |
Terminated 3 on December 07, 2015 |
Recall Number |
Z-2190-2015 |
Recall Event ID |
71525 |
Product Classification |
Needle, biopsy, cardiovascular - Product Code DWO
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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. |
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) |
Recalling Firm/ Manufacturer |
Mermaid Medical A/S Frydensbergvej 25 Stenl?se Denmark
|
For Additional Information Contact |
Mermaid Medical's Customer Care 720-420-9999
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Manufacturer 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.
|
FDA Determined Cause 2 |
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: 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. |
Quantity in Commerce |
320 |
Distribution |
US Distribution to FL including PR. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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