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Recall Observatory FDA recall evidence

Device product

Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 510491, Disposable Single Infusion Pump for drug delivery

Z-1459-2013

May 10, 2013

Class I

Product summary

Firm
Symbios Medical Products, LLC
Event
Event 65192
Status
Terminated
Classification
Class I
Quantity
33, 543 for all kits
Official record key
device-enforcement:Z-1459-2013

Official wording

Reason: 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

Code information: Pump Part 510490, Lot 11-100379- Lot 12-101132 found in: GoBlock Kit 510491, Lot 11-100601 to 13-100705

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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