The Medical Device Control Office in Hong Kong sent out several field safety notices warning of issues with products by Boston Scientific (Natick, MA). The field safety notices warned that labeling problems with the company’s balloon catheters, thermoplasty catheters and balloon dilators could impact consumers and healthcare providers.
In one batch of Rigiflex II single-use Achalasia balloon dilators by Boston Scientific, regulators in Hong Kong noted a typo in the expiration date for the devices. While the products are not expired, the dates are listed as “0213-12” instead of “2012-12.”
The company’s Alair Bronchial thermoplasty catheter also had incorrect expiration dates. The dates on the outer package show an expiration that that is two years beyond the expiration date listed on the inner label. However, Boston Scientific stated that all the mislabeled products are safe for patient use until the expiration date on the outer packaging.
Regulators in Hong Kong also recalled the company’s NephroMax high pressure nephrostomy balloon catheters and three batches of the catheter kits that come with the device. According to regulators, the devices come with the incorrect renal sheth size inside the included packaging. Boston Scientific stated that it has received at least five complaints from a batch that didn’t contain the correctly-sized sheath. The company is urging consumers to review these kits before use.
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