Maquet/Getinge/Atrium—PVC Right Angle Thoracic Catheters: Sterility May Be Compromised

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In an October 29, 2018, Urgent Medical Device Recall Product Removal letter submitted by an ECRI Institute member hospital, Getinge/Atrium states that the bottom seal of the sterile barrier pouches of the above catheters may be unsealed, potentially increasing the risk of product contamination, which may increase the risk for patient infection. Getinge/Atrium also states that the severity of the possible clinical complications depends on the degree of contamination of the device, the microorganisms involved, and the patient's risk factors. Getinge/Atrium further states that affected devices can be identified by grasping the Chevron seal to open the pouch as directed in the instructions for use (IFU); the device will drop through the bottom of any affected pouches. Getinge/Atrium has received no reports of patient injury related to this problem. The manufacturer has not confirmed the...