Stryker Pulls Drainage Set Due to Possible Catheter Breakage

Stryker is recalling its Fuhrman pleural and pneumopericardial drainage set because of the potential for the device’s catheter to break during insertion.

The recall, designated as Class 1 by the FDA, involves 34 devices, which were manufactured from Nov. 6, 2009 to Oct. 21, 2011, and distributed between Dec. 12, 2009 and Oct. 28, 2011.

The company received reports that the catheter included in the drainage set broke off in the pleural cavity of two patients, according to an FDA recall notice. The agency says both cases resulted in the need for medical intervention, and that this issue could cause serious patient injury or death.

The device is used to remove air from the pericardium or to drain air or fluid from the pleural cavity that protects the lungs.

Stryker sent notification letters Nov. 17, 2015, telling customers to discontinue use of the product and explaining steps to return affected devices. The voluntary recall was issued by Stryker for the sets, which were originally manufactured by Cook Medical.

The devices subject to recall are part of Stryker’s expired/unused program, which is strictly a sterilization service for open, unused devices. Devices sterilized through the service were not used clinically prior to being sent to Stryker for repackaging and sterilization, the company says.

Single-use devices remanufactured and reprocessed by Stryker are not affected by the recall, Chris Sugg, the senior director of regulatory affairs and quality assurance at Stryker Sustainability Solutions, said.

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