ARROW Pressure Injectable PICC Kit 의 리콜

Recall

RC-2017-RN-00986-1

Class III

2017-08-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00986-1

As a precaution, arrow international has initiated a recall for this product because these finished good kits may potentially contain an incorrect component. this issue came to light through an internal inspection. a 4fr single lumen catheter was found in a 5fr double lumen kit. through investigation at the manufacturing facility it was determined that there is a potential that the reverse scenario could also have occurred, 5fr double lumen catheter ending up in a 4fr kit thus both product codes/lots are in scope of the action. zero complaints have been received for this issue (either scenario) furthermore no product has been found internally for 5fr catheter in a 4fr kit.

Teleflex is requesting that customers: 1. Provide the customer letter to all who need to be aware of it within their organisation. 2. Inspect any stock on hand. The kit tray is transparent & does not need to be opened to determine the type of included catheter. 3. Lift the non-sterile pouch with the product information up to identify if the catheter has a single or double lumen. 4. Once all stock has been inspected, complete the Acknowledgement Form supplied with the customer letter with the details obtained during inspection. Note - include details of all stock implicated in this issue. 5. Return the completed & signed form to austcs@teleflex.com by 1 September 2017. If stock contains a 4FR Single lumen catheter – there is no impact and the stock can be used as normal. If stock contains a 5FR Double lumen catheter – this stock is impacted. In the event you have impacted stock a customer service team member will be in contact with you to arrange collection of the goods.