SynReam Reaming Rod 2.5mm, L 650mm, sterile(re-usable surgical instrument supplied as part of the SynReam Reaming medullary reaming system) 의 리콜

Recall

RC-2016-RN-01372-1

Class II

2016-10-20

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01372-1

An issue has been identified where peel pouches for certain lot numbers of reaming rods are de-laminating. this may lead to surgical staff members experiencing difficulty in opening the peel pouches and potentially causing the sterile device to come in contact with a non-sterile layer of the pouch.In the event there is difficulty in opening the sterile peel pouch a surgical delay may occur while a replacement part is located or while re-sterilisation is performed. if surgery cannot be completed without the sterile part and no alternate is available, the procedure may need to be rescheduled. if there is delamination of the peel pouches the layering and fragments may compromise the sterility of the part, which may place the patient at risk for infection.

Johnson & Johnson is advising customers to immediately quarantine affected product. Affected product may then be returned to Johnson & Johnson for replacement or unopened affected product may be re-sterilised per the product Sterilisation Instructions contained within the Instructions for Use provided with the product.