EXACTAMIX Inlets 의 안전성 경고

Safety alert

2018-05-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180507c.html

Medical device safety alert: baxter healthcare exactamix inlets medical device manufacturer, baxter healthcare, has issued a medical device safety alert concerning its exactamix inlets, details of product are identified as below: exactamix inlet. non-vented, high-volume inlet; product code: h938173; lot number (corrected expiration date) 802278 (9/2018), 802383 (10/2018), 802385 (5/2018) exactamix inlet. vented, high-volume inlet; product code: h938174; lot number (corrected expiration date): 802279 (8/2018), 802280 (8/2018) exactamix inlet. syringe inlet; product code: h938176; lot number (corrected expiration date) 802286 (9/2018) the manufacturer is issuing a voluntary product recall for the above lots due to incorrectly performed over-labeling. the inlets were over-labeled with a blank label, or with a label containing an extended expiration date. according to the manufacturer, the use of an affected inlet that may have lost its sterility due to being used past its actual expiration date may result in a bloodstream infection or other serious adverse health consequences. the customers are required to locate and remove all affected product lots from their facility. according to the local supplier, there are no serious injury and adverse event reported in hong kong. the affected products are distributed in hong kong between 2 june 2017 and 15 february 2018. if you are in possession of the products, please contact your supplier for necessary actions. updated on 10 may 2018.