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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 008 06 12 000 |
| Date submitted: |
6/2/2012 |
| Manufacturer: | Covidien Ltd. |
| Device Type: | Surgical Stapler, ROTICULATOR™ Single Use Stapler |
| Description: | Surgical, Single Use Stapler |
| Medical Device Identifier: | Surgical Stapler, ROTICULATOR™ Single Use Stapler
Ref# Product description
017612 ROTICULATOR™ 55-3.5 Single Use Stapler
017614 ROTICULATOR™ 55-4.8 Single Use Stapler
017615 ROTICULATOR™ 30-3.5 Single Use Stapler
017617 ROTICULATOR™ 30-4.8 Single Use Stapler
017619 ROTICULATOR™ 30-V3 Single Use Stapler
Any Lot # starts with the following must be retrained:
P7E, P7F, P7G, P7H, P7J, P7K, P7L, P7M, P8A, P8B, P8C, P8D, P8E , P8F, P8G, P8H, P8J, P8K, P8L, P8M, P9A, P9B, P9C, P9D, P9E , P9F, P9G, P9H, P9J, P9K, P9L, P9M, P0A, P0B, P0C, P0D, P0E , P0F, P0G, P0H, P0J, P0K, P0L, P0M, P1A, P1B, P1C, P1D, P1E , P1F, P1G, P1H, P1J, P1K, P1L, P1M, P2A, P2B0153X
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| Reason of Field Safety Corrective Action: | Sterile Barrier May Be Compromised |
| Remedy Action: | Immediately identify and quarantine all affected inventory. All affected ROTICULATOR™ units must be returned |
| Athorized Representative/Importer/Distributor: | FAROUK, MAAMOUN TAMER & COMPANY, Riyadh, (01) 4142200 |
| Report Source: | NCMDR |
| Source Ref. Number: | 42AFA6CEE734C |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: | No Attachments |
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