Hong Kong’s Medical Device Control Office sent out 3 field safety notices warning hospitals and consumers of labeling problems with a trio of Boston Scientific (NYSE:BSX) products: a balloon dilator, a thermoplasty catheter and a balloon catheter kit.
A single batch of Boston Scientific’s Rigiflex II single-use Achalasia balloon dilators are labeled with a typo in the expiration date, and the company is asking consumers to return the mislabeled devices. The products are not expired and there is no risk to patients, the healthcare giant warned, but the expiration dates are listed as "0213-12" rather than "2013-12".
Another product, the Alair Bronchial thermoplasty catheter, also came off the line with some mixed-up expiration dates, with the outer packaging denoting a "2014-04" date, 2 years beyond the "2012-04" date listed on an inner label. Boston Scientific said these mislabeled products are all safe to use until the date on the exterior packaging.
The last product in question is being recalled after the company found that 6 batches of the NephroMax high pressure nephrostomy balloon catheters and 3 batches of the catheter kits contain the wrong renal sheath size inside the packaging. The device maker has received at last 5 complaints stemming from a single batch where the product was labeled as a 30Fx20cm sheath but instead contained a 24Fx17cm sheath, according to the warning.
Boston Scientific is advising customers to carefully review kits before using them and to return questionable products.
BSX shares were up 0.8% to $9.37 as of about 12:35 p.m. EST today.