FDAClass IJune 12, 2013

Part 510636 Disposable Infusion Pump recall

Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the…

Why was Part 510636 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 510636 , Lot 11-100632- Lot 12-101233 found in: GoBlock Kit 510646, Lot 11-100632- Lot 12-101233

Product
Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the…
Recalling firm
Symbios Medical Products, LLC
Quantity
33543
Distribution
US Nationwide distribution.
Recall date
June 12, 2013
Classification
Class I
Status
Terminated
Agency
FDA (device)
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