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Symbios Medical Products, LLC Recall: GOPump Elastometric infusion PumpKit with/ and witho

Symbios Medical Products, LLC Recall: GOPump Elastometric infusion PumpKit with/ and witho is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Symbios Medical Products, LLC; Product: GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number

Recalling firmSymbios Medical Products, LLC
ProductGOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer. The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management
Reason for recallReceived 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.
ClassificationClass I (most serious — reasonable probability of serious health consequences or death)
StatusTerminated
DistributionNationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA.
Recall initiated20130225
Recall numberZ-0940-2013
Categorydevice
StateIN
CountryUnited States

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