MINISEND-LUER LOCK CAP 에 대한 현장 안전성 서한

Field Safety Notice

SN201401

2014-02-11

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/minisend-luer-lock-cap&id=3579f825-9782-6eee-9b55-ff00008c97d0

A potential fault has been identified with the sealing of the primary packaging (blister) of the minisend luer lock cap, leading to a possible loss of sterility of the product. not all units are affected, only those with a small sealing surface.  the manufacturer has confirmed that devices on the irish market, with product reference codes tp-mf and tp-mf-a are affected by this action. refer to attached field safety notice (fsn).

Sendal S.L. requires that users check their inventory and quarantine all affected products/lots. In the absence of an alternative, it is recommended that users verify the integrity of the packaging and do not use units where the sealing appears defective.  Sendal requires that users return completed verification forms for this action to the Sendal representative.  The IMB recommends that users forward this safety notice to all those who need to be aware of this action within your organisation and to maintain awareness over this safety notice for an appropriate time period.