Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1457-2013 — Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the following kits GoBlock Kit 510472, Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local

U.S. FDA — Device Enforcement · United States · 2013-05-10 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1457-2013
Date of alert
2013-05-10
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Symbios Medical Products, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
130100137
Reported risk: Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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