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Symbios GOPump Elastomeric Infusion PumpKit Recalled Due to Faulty Flow Restrictor Bead Causing Dangerous Flow Rate, Potential for Serious Injury


The Symbios GOPump has been recalled due to a defective GOPump Elastomeric Infusion PumpKit with and without accessories all containing Dual GOPump, part number 510076: one infusion pump comprising two 150 mL elastomeric reservoirs in which each connects to its own catheter. The liquid flow rate is labeled at 2 mL/hr per elastomer on the GOPump Elastomeric Infusion PumpKit. 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.

 

The flow restrictor bead may become displaced from its fitting which may permit solutions to flow at a higher rate than intended. This product may cause serious adverse health consequences, including death. The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

The kit part number and lot number may be found on the outer kit box labeling. If the pump has been removed from the outer kit box, the pump part and lot number may be found on the sterile barrier packaging. If the pump has been removed from the sterile barrier packaging, the pump lot number is the first eight digits of the serial number label, found on the base of the pump. These kits were distributed between September 10, 2012, and February 11, 2013.

 

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