Askina Gel and Calgitrol Paste 의 안전성 경고

Safety alert

2018-05-02

2018-05-02

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180502a.html

Medical device safety alert: b. braun hospicare ltd askina gel and calgitrol paste medical device manufacturer, b. braun hospicare ltd., has issued a medical device safety alert concerning its askina gel and calgitrol paste [article number: 14291, 001419n, 001419nru, 001419s, 001419sbr, 001419ses, 001419sescp, 001419sf, 001419sfr, 001419sru, 6241001, 6241505, 6241505f, 6241510, 6242501, 6242501fr, 6245001]. in the manufacturing site, it was determined that the irradiation dose qualified for sterilization of the above mentioned products was too low. in consequence, the germ reduction through gamma irradiation may not have reached the requested sterility assurance level of 10-6. the effect cannot be limited to specific batches. according to the manufacturer, there was no market feedback on any adverse patient outcome which could be associated to the above described observation. however, the manufacturer decided to recall the affected products from the market as a preventive measure. the affected users are asked to take the following actions: identify and quarantine the affected devices; do not use affected devices anymore; patients with affected devices in use should be monitored carefully. if clinically uneventful, an exchange of the product is not indicated. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 may2018.