Symbios Medical Recalls GoPump and GoBlock Kits Due to Flow Rate Issues
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 due to reports of excessively high flow rates.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (excessively high flow rates) that poses a risk of harm, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the criteria for a High severity score.
Plain-English summary
Symbios Medical Products, LLC, of Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in GoPump Rapid Recovery System kits and all GoBlock kits. The recall includes units manufactured with flow control components assembled prior to July 2012. The affected products include the Part 510490 Disposable Infusion Pump and the 2 mL/hr GoPump (PN510031) with a 150 mL reservoir.
The recall is being expanded after the company received additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GoPump. The recall covers 33,543 units for all kits, which were distributed nationwide in the United States. Affected lot numbers include Pump Part 510490, Lot 11-100379 to Lot 12-101132, and GoBlock Kit 510491, Lot 11-100601 to 13-100705.
Consumers and healthcare facilities should stop using the affected products and contact Symbios Medical Products for further instructions or a replacement.
The recalled product
- 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
- Manufacturer
- Symbios Medical Products, LLC
- Category
- Medical Device — Infusion Pumps
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Pump Part 510490
- Lot 11-100379- Lot 12-101132 found in: GoBlock Kit 510491
- Lot 11-100601 to 13-100705
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Symbios Medical Products, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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