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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 137 10 18 000 |
| Date submitted: |
10/24/2018 |
| Manufacturer: | Lifetech Scientific (Shenzhen) Co., Ltd. |
| Device Type: | Cera Vascular Plug Systems |
| Description: | Vascular Closure Devices |
| Medical Device Identifier: | LT-PLUG-04
1721010410180107211801070372, 1721010410180107211801070373, 1721010410180107211801070374, 1721010410180107211801070375, 1721010410180107211801070376, 172101041018010721801070377 180107
LT-PLUG-04
1721011810180134211801340251, 172101181018013421801340252, 1721011810180134211801340253, 1721011810180134211801340254, 1721011810180134211801340255, 1721011810180134211801340256, 1721011810180134211801340258, 1721011810180134211801340259, 1721011810180134211801340260 180134
LT-PLUG-06
1720122710171252211712521320, 1720122710171252211712521321, 1720122710171252211712521322, 1720122710171252211712521323, 1720122710171252211712521327, 1720122710171252211712521328, 1720122710171252211712521329, 1720122710171252211712521330 171252
LT-PLUG-06
1721010410180107211801070384, 1721010410180107211801070385, 1721010410180107211801070386, 1721010410180107211801070387, 1721010410180107211801070388, 1721010410180107211801070389 180107
LT-PLUG-06
1721012410180146211801460777, 1721012410180146211801460778, 1721012410180146211801460779 180146
LT-PLUG-06 1720122710171252211712521325, 1720122710171252211712521324 171252
LT-PLUG-06
1721012410180146211801460780, 172101241018014621801460781 180146
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| Reason of Field Safety Corrective Action: | Lifetech states that the size of the loader of the above systems may be too small, potentially causing difficulty for the matching delivery cable to pass through. Lifetech also states that this problem can be noticed during pre-operative preparation, and that potential hazards include a delay in procedure and the need to replace the loader. Lifetech further states that this problem occurs because the inner diameter of the loader did not reach its lower limit, which was caused by the manufacturing process problem of the supplier. |
| Remedy Action: | Identify, isolate, and discontinue use of any affected systems in your inventory.
A Lifetech representative will contact your facility arrange for product replacement and reimbursement.
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| Athorized Representative/Importer/Distributor: | Ameesa Medical Instruments |
| Report Source: | BfArM |
| Source Ref. Number: | A31521(ECRI), 12399/18 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: |  Lifetech Scientific.pdf |
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