Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Interject Injection Therapy Needle Catheter [Universal Product Number: M00518151; Lot Number: 19319825] & Mustang PTA Balloon Peripheral Angioplasty Catheter [Universal Product Number: H74939171031510; Lot Number: 19296330].
The manufacturer is notifying all affected users of a potential sterile barrier breach on twelve Interject Injection Therapy Needle Catheters and two Mustang PTA Balloon Peripheral Angioplasty Catheters, after receiving one complaint from the field. If these products have been used in patients, the potential complication associated with sterile barrier breach is increased risk of infection necessitating hospitalization for antibiotic therapy.
Affected users are instructed to immediately segregate the affected products and return them to the manufacturer for product replacement.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 October 2016