Symbios Recalls GoPump and GoBlock Kits Due to Flow Control Defects
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured with flow control components assembled prior to 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 defect (excessively high flow rates) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Symbios Medical Products, LLC is voluntarily recalling all GoPumps found in 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 the company received additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031).
The affected products include the Part 510121 Disposable Infusion Pump (Elastomeric Pump 300 mL, 4mL/hr) found in various GoPump and GoBlock kits. The recall covers 33,543 units in all kits distributed nationwide in the United States. Specific lot numbers for the pump and kits are listed in the agency's structured data.
Consumers and healthcare providers should stop using the affected kits and contact Symbios Medical Products for further instructions. The recall is voluntary and is being conducted by the manufacturer in Indianapolis, Indiana.
The recalled product
- Product
- Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits GoPump Kit 510203-BP, Epidural catheter & BIOPATCH GoPump Kit 510204, 2.5" Fenestrated catheter GoPump Kit 510204 BP, 2.5 Fenestrated catheter & Biopatch GoPum
- Manufacturer
- Symbios Medical Products, LLC
- Category
- Medical Device — Infusion Pump
- Affected units
- 33,543
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 (4)
- Pump Part 510121
- Lot 11-100505 to 11-1-665 GoPump Kit 510204 BP
- Lot 11-100721 to 13-100680 GoPump Kit 510205BP
- Lot 11-100722 to 13-100087 GoBlock kit 510608
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 Recalls GoPump Rapid Recovery System Kits Due to Flow Control Defect
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
- HighSymbios Medical Recalls GoPump and GoBlock Kits Due to Flow Rate Issues
FDA (Devices) · 2013-06-12