"Concerns Over Drug Leakage" ... MFDS Recalls Direct Drug Injection Devices
No Leakage Cases Reported Domestically
[Asia Economy Reporter Jo In-kyung] The Ministry of Food and Drug Safety is recalling the drug direct infusion devices imported and sold by the medical device wholesaler Becton Dickinson Korea.
On the 20th, according to the Ministry of Food and Drug Safety, among the products imported under the name 'BD ConnectaTM Stopcock,' cases of drug leakage were reported in specific manufacturing numbers (1060784, 1063417, 1126371, 1152275). Following the announcement by the Australian Therapeutic Goods Administration, a recall decision was made domestically for 387,400 units of these products.
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The drug direct infusion device is a medical device used by connecting it to catheter-like tube devices used for injecting needles or drugs. Although no cases of drug leakage due to the use of this product have been reported in Korea so far, the Ministry of Food and Drug Safety explained that the recall was decided as a precautionary measure.
The Ministry of Food and Drug Safety urged, "Medical device distributors and medical institutions should not distribute or use products with the recalled manufacturing numbers and return them to the place of purchase or to Becton Dickinson Korea."
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