Johnson and Johnson recalls narcotic pain system sold in Europe

The product was originally approved here in the US, but when a change in manufacturing processes was made, it has not been approved with being resubmitted to the FDA. Interesting how a company goes about improvements to a product, and then gets rejected. Half of the 13,000 devices sold have been returned, but the amount of money made on the product may not be enough to pursue to market here, but the jury is still out.

The reason for the recall is that some of the units could potentially activate themselves and with containing powerful pain relief products, this was not good. When I read this as being the reason for the recall, it sounds like the issues might be in the software end of the product, a real concern for all manufacturers of medical devices, and you can’t run out and find human beta testers here by any means.

As posted earlier this week, consumer products though are still a big mainstay with J and J and part of the most profitable portions of the business. BD

TRENTON, N.J. (AP) — A Johnson & Johnson company is recalling an advanced pain patch system for post-surgery hospital patients after some units of the needleless system were found to possibly be able to activate themselves, posing a potential risk of narcotic overdose.

The Ionsys transdermal system has been recalled from the 11 countries in Europe where it has been on the market since being launched in January, Greg Panico, a spokesman for J&J's Ortho McNeil unit, said Thursday. The defect was found among products being prepared for shipment at a distribution center, he said, and there have been no reports of patients being harmed.

The product has never been on the market in the U.S., although it was approved at one point.

Ionsys was designed as an advance over current systems that let hospitalized patients with significant pain press a button to get an intravenous dose of a powerful painkiller. Instead, it uses a low-intensity electrical field, barely noticeable to the patient, that rapidly moves the drug inside into the patient's skin and then bloodstream, according to Panico.