U-100 Insulin Syringe 0.5mL 27G and 29G 의 리콜

Recall

RC-2018-RN-00171-1

Class II

2018-02-23

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00171-1

Taechang industrial is initiating a recall of all lot numbers of terumo branded u-100 insulin syringe with a capacity of 0.5ml x 27g and 29g due to incorrect information contained on the device peel pack.The statement:"0.5ml single use syringe for 100 units or less in two unit increments"is incorrect and should state:"0.5ml single use syringe for 50 units or less in one unit increments"in essence, the 0.5ml peel packs have been inadvertently printed with information intended for the 1.0ml peel pack. the printing on the syringes themselves is correct.

Terumo is requesting customers: 1. Review the supplied urgent medical device recall (permanent removal) notification, inspect all stock on hand and quarantine affected lot numbers prior to return as per the instructions given in the customer letter. Ensure all relevant staff are made aware of this recall; 2.If any of the recalled product could have been transferred from your facility to another, please immediately notify that facility know of this recall; 3.Where possible, return all affected stock to your supply department for consolidated return to Terumo Australia as per the instructions given; and 4.Terumo will be providing credit for all returned stock. Replacement stock will not be automatically issued. Please process a new order if more stock is required.