The FDA this week labeled Stryker‘s (NYSE:SYK) Fuhrman & Pneumopericardial drainage set recall as Class I. The recall was issued over problems with the device breaking off in the pleural cavity during insertion.
The federal watchdog labeled the recall as a Class I, the most serious type of recall issued by the FDA, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The recall affects 34 devices in the U.S. with item number G03974, manufactured between Nov. 6, 2009 and Oct. 21, 2011 and distributed between Dec. 12, 2009 and Oct. 29, 2011, according to the FDA release.
A total of 13 different lot numbers were indicated in the recall, distributed to Alaska, California, Florida, Indiana, New York, North Carolina, Oregon and Wisconsin.
The device is used to remove air or fluid from the pericardium surrounding the heart or from the pleural cavity that protects the lungs.
Stryker said it received 2 reports in which the catheter included in the drainage set broke off in the pleural cavity during insertion, with each case requiring the need for medical intervention. The FDA said the error could cause serious patient injury or death.
Stryker advised customers with the set to discontinue use of the product, complete the appropriate recall forms and return them to Stryker, as well as returning any products indicated by the recall form.