 |
Your changes have been successfully saved |
|
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
|
|
|
|
 |
|
 |
|
NCMDR Recall
| Reference Number: |
mdprc 062 11 16 000 |
| Date submitted: |
11/10/2016 |
| Manufacturer: | Teleflex Medical |
| Device Type: | ARROW OnControl Biopsy System Tray |
| Description: | Bone Marrow Biopsy System |
| Medical Device Identifier: |
Product Codes: 9403‐EU‐006, 9403‐VC‐006, 9408‐EU‐006, 9408‐VC‐006, 9411‐EU‐006, 9411‐VC‐006, 9451‐VC‐006, 9458‐VC‐006, 9461‐VC‐001, 9461‐VC‐006, 9462‐EU‐001, 9462‐VC‐001, 9462‐VC‐006, 9463‐EU‐001, 9463‐VC‐001, 9463‐VC‐006, 9464‐EU‐001, 9464‐VC‐001, 9464‐VC‐006, 9465‐VC‐001, 9465‐VC‐006, 9466‐EU‐001, 9466‐VC‐001, 9466‐VC‐006, 9470‐VC‐006, 9471‐VC‐006, 9472‐VC‐006
Multiple lot numbers of the affected device are provided in the attached FSN.
|
| Reason of Field Safety Corrective Action: | Teleflex is recalling this product due to a potential incomplete seal on the outer sterile package.
Because of the compromised packaging, the sterility of the inside drape, which is used in preparation for bone marrow aspiration with the OnControl system, cannot be guaranteed. If sterility of the drape is compromised, there is a potential for infection to occur.
|
| Remedy Action: | Immediately discontinue distribution and quarantine any affected products listed above. Return the affected device to the manufacturer |
| Athorized Representative/Importer/Distributor: | Ebrahim M. Al-Mana & Bros. Co. Ltd. |
| Report Source: | NCMDR |
| Source Ref. Number: | 99D7E0CE4B369 |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: |  Teleflex Medical.pdf |
|
|
 |
|
 |
|
|