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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00171-1
Product Name/Description U-100 Insulin Syringe 0.5mL 27G and 29G

Lot Numbers for product SS*05M2713KA:
7D700, 7E700, 7F731, 7G719, 7I701, 6H713,6K700

Lot Numbers for product SS*05M2913KA :
7A713, 7G720, 7I7012, 7A713, 7B728, 6F700, 6F706

ARTG: 234082 (Terumo Australia Pty Ltd - Insulin syringe, fixed-needle)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 23/02/2018
Responsible Entity Terumo Australia Pty Ltd
Reason/Issue 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.
Recall Action Recall
Recall Action Instructions 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.

This action has been closed out on the 22/11/2018.
Contact Information 1800 837 866 - Terumo Customer Service