FDA Class I Recall For Symbios GOPump Elastomeric Infusion PumpKit

In short

The FDA has issued its highest classification of recall for the Symbios MedicalĀ GOPump Elastomeric Infusion PumpKit with and without accessories all containing Dual GOPump, part number 510076.

Background

The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system using an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.

According to the recall notice, the flow restrictor bead may become displaced from its fitting which may permit solutions to flow at a higher rate than intended. By issuing a Class I recall, FDA is effectively warning that this product may cause serious adverse health consequences, including death.

Affected part numbers can be found on the recall notice, here.

Customers are being asked to immediately remove all affected GOPump kits from inventory (regardless of its location) and segregate this product in a secure location for return to Symbios Medical Products.

Source: FDA