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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 093 08 14 000 |
| Date submitted: |
8/20/2014 |
| Manufacturer: | Baxter Healthcare |
| Device Type: | DURA-GUARD, PERI-GUARD, and VASCU-GUARD |
| Description: | BioSurgery |
| Medical Device Identifier: | Codes: PC0404N, PC0608N, PC1225N, DG0209SN, DG0404SN, DG0608SN, DG0814SN, VG0106N, VG0108N, VG0209N.
All Batch numbers
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| Reason of Field Safety Corrective Action: | Synovis and Baxter Healthcare would like to notify you of a communication that is being sent to remind our customers of the approved indications for use for the DURA-GUARD, PERI-GUARD, and VASCU-GUARD products. |
| Remedy Action: | While the manufacturer believes that the product labeling is well differentiated to prevent inadvertent misuse, as a conservative approach this reminder of correct product usage is being sent.
Peri-Guard has the following approved indication: For use as a prosthesis for pericardial closure and soft tissue deficiencies which include: defects of the abdominal and thorocic wall, hernias (diaphragmatic, femorol, incisionol, inguinal, lumbar, parae%stomy, scrotal and umbilical), and intracardiac and great vessel repair.
Vascu-Guard is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial blood vessels and arteriovenous access revisions.
Only Dura-Guard is intended for use as a dura substitute for the closure of dura mater during neurosurgery. It is differentiated from other products with a different outer package color (Dura-Guard is grey, whereas the others are green), as well as an image of a brain on the exterior.
The attached customer letter provides the correct indications for each product, as well as information about distinguishing labeling designed to ensure correct usage.
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| Athorized Representative/Importer/Distributor: | Baxter AG |
| Report Source: | NCMDR |
| Source Ref. Number: | FA373A4B221D8 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: |  Baxter Healthcare.pdf |
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