Symbios Recalls GoPump and GoBlock Kits Due to Flow Control Defects
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 due to flow control components that may cause 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 defect causing excessively high flow rates, which poses a risk of harm, but the source text does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Symbios Medical Products, LLC is voluntarily recalling all GoPumps found in GoPump Rapid Recovery System kits and GoBlock kits. The recall includes units manufactured with flow control components assembled prior to July 2012. The company is expanding the recall after receiving reports of excessively high flow rates on specific pump models.
The Symbios GOPump Rapid Recovery System is a local pain management system that uses a balloon inflated with local anesthetic medication. The recalled items include Part 510449 Disposable Infusion Pumps and GoBlock Kit 510472. Affected lot numbers for the pumps range from 11-100271 to 130100137, and for the kits from 11-100385 to 13-100354.
The products were distributed nationwide in the United States. Consumers and healthcare providers should check their inventory for these specific part and lot numbers and stop using the affected devices.
The recalled product
- Product
- 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 in
- Manufacturer
- Symbios Medical Products, LLC
- Category
- Medical Device — Infusion Pump
- 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 510449
- Lot 11-100271 - Lot 130100137 found in: GoBlock Kit 510472
- Lot 11-100385 to 13-100354
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
Same manufacturer · Symbios Medical Products, LLC
See all →- HighSymbios Medical Recalls GoPump and GoBlock Kits Due to Flow Rate Issues
FDA (Devices) · 2013-06-12
- HighSymbios Recalls GoPump and GoBlock Kits Due to Flow Control Defects
FDA (Devices) · 2013-06-12
- CriticalSymbios Recalls GoPump and GoBlock Kits Due to High Flow Rates
FDA (Devices) · 2013-06-12
- SevereSymbios Recalls GoPump Infusion Pumps Due to High Flow Rates
FDA (Devices) · 2013-06-12
- HighSymbios Recalls GoPump and GoBlock Kits Due to High Flow Rates
FDA (Devices) · 2013-06-12
Same hazard · excessive flow rate
See all →- HighICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate Risk
FDA (Devices) · 2014-10-01
- HighICU Medical Recalls Stat 2 Flow Controllers Due to High Flow Rate Risk
FDA (Devices) · 2014-10-01
- HighICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate
FDA (Devices) · 2014-10-01
- SevereICU Medical Recalls Stat 2 Flow Controllers Due to Flow Rate Issues
FDA (Devices) · 2014-10-01
- CriticalSymbios Recalls GoPump Rapid Recovery System Kits Due to Flow Rate Issues
FDA (Devices) · 2013-06-12