Monoject Prefill Flush Syringe 의 안전성 경고

Safety alert

2013-08-20

2013-08-20

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130820.html

Medical device safety alert: covidien monoject prefill flush syringe the united states food and drug administration (fda) has posted a press release issued by covidien concerning a voluntary recall of certain lots of monoject prefill flush syringes. the affected products are identified as follow:- monoject 0.9% sodium chloride flush syringe, 12 ml syringe with 10 ml fill product id: 8881570121 lot number: 13a0084n, 13a0094, 13b0364, 13c0504, 13c0514 monoject 0.9% sodium chloride flush syringe, 12 ml syringe with 3 ml fill product id: 8881570123 lot number: 13a0084n monoject 0.9% sodium chloride flush syringe, 12 ml syringe with 5 ml fill product id: 8881570125 lot number: 13a0084n monoject 10 units/ml heparin lock flush, 12 ml syringe with 10 ml fill product id: 8881580121 lot number: 13a0084n monoject 10 units/ml heparin lock flush, 12 ml syringe with 3 ml fill product id: 8881580123 lot number: 13a0084n monoject 10 units/ml heparin lock flush, 12 ml syringe with 5 ml fill product id: 8881580125 lot number: 13a0084n monoject 100 units/ml heparin lock flush, 12 ml syringe with 10 ml fill product id: 8881590121 lot number: 13a0084n monoject 100 units/ml heparin lock flush, 12 ml syringe with 3 ml fill product id: 8881590123 lot number: 13a0084n monoject 100 units/ml heparin lock flush, 12 ml syringe with 5 ml fill product id: 8881590125 lot number: 13a0084n, 13d0824n the recall is being conducted due to the risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process. these products are labeled as either sodium chloride flush or heparin lock flush. some of these syringes have the mismatched syringe tip cap, syringe label, filled volume and wrapper. however, for the sodium chloride flush syringes with matched tip cap, syringe label, filled volume and wrapper, there are no visual cues for the clinician to identify the problematic products. if non-sterile fluid is administered there is a health risk of life-threatening infection to the blood stream or other areas. besides, if the clinician uses the heparin lock flush syringe containing only water on peripheral or venous catheters, the patency of the intravascular device may not be maintained and clotting may occur. this could result in non-functional intravenous access requiring the device to be replaced the affected users are required to identify, segregate and return any affected products in their inventory. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following fda website: http://www.Fda.Gov/safety/recalls/ucm365577.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 august 2013.