FDAClass IJune 12, 2013

Part 510490 Disposable Infusion Pump recall

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

Why was Part 510490 Disposable Infusion Pump recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 510491…
Recalling firm
Symbios Medical Products, LLC
Quantity
33, 543 for all kits
Distribution
US Nationwide distribution.
Recall date
June 12, 2013
Classification
Class I
Status
Terminated
Agency
FDA (device)
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