Symbios Recalls GoPump Infusion Pumps Due to High Flow Rates
Symbios Medical Products is voluntarily recalling GoPump infusion pumps and kits due to reports of excessively high flow rates.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class I. According to the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.
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 pumps and kits manufactured with flow control components assembled prior to July 2012. The specific product affected is the Part 510031 Disposable Single Infusion Pump, which has a total volume of 150 mL and a continuous delivery rate of 2 mL/hr.
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 affected products are distributed nationwide in the United States. The recall covers 33,543 units in all sizes and kits.
Consumers and healthcare providers should stop using the affected GoPump kits and pumps immediately. Symbios Medical Products is the recalling firm. The affected lots include Pump 510031 (Lot 11-100106 to Lot 12-101133) and various GoPump Kit lots as detailed in the agency's structured data.
The recalled product
- Product
- Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO... found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit 51004
- 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 (8)
- Pump 510031
- Lot 11-l 00106 to Lot 12-101133 Kit 510042
- lots 11-100251 to 13-100128 Kit 510042-BP
- lot 12-101300 Kit 510110
- lot 11-100664 Kit 510110-BP
- Lots 11-100838 to 12-101560 Kit 510350
- Lots 11-100353 to 12-100233 Kit 510350-BP
- Lots12-100429 to 13-100047 Kit 510556-BP Lots 11-100779 to 12-101552
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
- HighSymbios Recalls GoPump and GoBlock Kits Due to Flow Control Defects
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- CriticalSymbios Recalls GoPump and GoBlock Kits Due to High Flow Rates
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- HighSymbios Recalls GoPump and GoBlock Kits Due to High Flow Rates
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- HighSymbios Medical Recalls GoPump and GoBlock Kits Due to Flow Rate Issues
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Same hazard · excessive flow rate
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- SevereICU Medical Recalls Stat 2 Flow Controllers Due to Flow Rate Issues
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- CriticalSymbios Recalls GoPump Rapid Recovery System Kits Due to Flow Rate Issues
FDA (Devices) · 2013-06-12