Physio-Control recalls AED electrodes made by by 3rd party

Physio-Control issued an urgent field safety notice recalling certain lots of its Quik-Combo adult pacing/defibrillation/ECG electrodes and its Red-Pak preconnected system due to a potential for damage to the wire insulation.

The company said that it hasn’t received any complains over the issue from customers, but that the use of products with the damaged insulation could result in an increased risk for reduced or no patient therapy, arcing of current, sparking and patient or clinician burns.

Physio-Control requested that customers with the device should quarantine the products and return them to the company, according to a safety field notice from the company.

The recall affects Adult-Edge electrodes with Quik-Combo connectors and Redi-Pak preconnect units with catalog number 11996-000017, with MIN number 3202674-005 and lot numbers 516907, 516815 and 519816.

Last month, Stryker (NYSE:SYK) said that it agreed to pay $1.28 billion to Bain Capital for automated external defibrillator maker Physio-Control.

Medtronic (NYSE:MDT) sold Physio-Control to Bain for $478 million in January 2012.

The all-cash deal, slated to close at the beginning of the 2nd quarter, is expected to add slightly to Kalamazoo, Mich.-based Stryker’s adjusted earnings per share this year. The company boosted its earnings outlook for the year to reflect contributions from Physio-Control and recent buy Sage Products, saying it now expects to post adjusted EPS of $5.57 to $5.77, up from guidance for $$5.55 to $5.75. The acquisitions are forecast to contribute 15¢ to 18¢ to adjusted EPS next year, Stryker said.

The post Physio-Control recalls AED electrodes made by by 3rd party appeared first on MassDevice.

from MassDevice http://ift.tt/1px53ti