Medical Device Advisories

FDA Advisory No. 2017-221 || VOLUNTARY RECALL OF THE TERUMO INSULIN SYRINGE WITH NEEDLE WITH DVR NO. 4378 OF THIS PRODUCT SOLD ONLY AT INDONESIA.

FDA Advisory No. 2017-221

VOLUNTARY RECALL OF THE TERUMO INSULIN SYRINGE WITH NEEDLE WITH DVR NO. 4378 OF THIS PRODUCT SOLD ONLY AT INDONESIA.

All are hereby advised by the Food and Drug Administration (FDA) about the voluntary recall of the following Terumo Insulin Syringe with Needle with DVR-4378 product code  distributed by Terumo (Philippines) Corporation 124 East Main Ave., Laguna Technopark, Biñan, Laguna, Philippines:

Product Code:

DVR – 4378

Description:

Terumo Syringe With Needle, Insulin, 26G x ½”

Product Name:

Product Code

Lot Numbers

Expiration Date

 

Terumo Syringe with Needle Insulin, 26Gx1/2”

 

SS+01N2613

160809D

160914D

161015D

161129D

161221D

2021-07

2021-08

2021-09

2021-10-31

2021-11-30

 

The cited products are being voluntarily recalled by Terumo (Philippines) Corporation because of the customer reports from its main manufacturer in other country on potential effect of the device. In the report, This recall has been initiated due to issue. Instead of labelling a product with U-40/U-80, labelling of the products indicated U-100. Immediately, a recall notification letter was provided to sales territory in Indonesia and specific instruction was made regarding the product to be recalled.

The total quantity of products produced and supplied is 518,400 pieces Last April 10, Terumo Indonesia recalled a total of 516,600 pieces. 1,800 pieces are not intended to be used for insulin injection according to the customer in Indonesia, therefore, the customer requested and confirmed that it should not be recalled or pulled out. Recalled or pulled-out product will be destructed. Distributors, retailer, hospitals that have any of the stated medical device product are instructed to discontinue further distribution, sale and use. All consumers are likewise advised not to purchase or use the affected product lots.

Any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to FDA at telephone no. (02) 857-1900 loc. 8301 or email us at This email address is being protected from spambots. You need JavaScript enabled to view it..

Dissemination of the information to all concerned is requested.

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