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Symbios Medical Products, LLC recalls GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One
Recalled March 20, 2013 · FDA recall Z-0940-2013 · Symbios Medical Products
Hazard
Received 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. · FDA Class I
Units
458
Sold at
Nationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA.
Description
Received 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.
Product
GOPump 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
Manufacturer(s)
Symbios Medical Products, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →