Symbios Recalls GoPump Rapid Recovery System Kits Due to Flow Control Defect
Symbios Medical Products is voluntarily recalling GoPump Rapid Recovery System kits and GoBlock kits manufactured before July 2012 due to reports of excessively high flow rates.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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.…"
Plain-English summary
Symbios Medical Products, LLC, 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 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 510076 Disposable Dual Infusion Pump and the Disposable Single Infusion Pump for drug delivery. These pumps are part of the Symbios GOPump Rapid Recovery System, a local pain management system that consists of a small balloon inflated with a local anesthetic medication. The recall covers 33,543 kits distributed nationwide in the United States.
Specific lot numbers are affected, including Pump 510076 Lot 11-100222 to 12-101087, Kit 510080 BP Lot 11-100215 to 12-100508, Kit 510141-BP Lot 12-100460 to 12-100673, and Kit 510112-BP Lot 11-100839 to 13-100225. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected products.
The recalled product
- Product
- Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile, found in the following kits: GoPump kit 510080-BP, 5 fenestrated catheter & BIOPATCH; GoPump kit 510112-BP, 2.5" fenestrated catheter & BIOPATCH Go Pump Kit…
- Manufacturer
- Symbios Medical Products, LLC
- Category
- Medical Device — Infusion Pump
- Hazard
- 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 (1)
- Lot 11-100839-to 13-100225
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 →- SevereSymbios Recalls GoPump Rapid Recovery System Kits Due to Flow Rate Issues
FDA (Devices) · 2013-06-12
- SevereSymbios Recalls GoPump and GoBlock Kits Due to Flow Control Defects
FDA (Devices) · 2013-06-12
- SevereSymbios Medical Recalls GoPump and GoBlock Kits Due to Flow Rate Issues
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
Same hazard · excessive flow rate
See all →- SevereICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate Risk
FDA (Devices) · 2014-10-01
- SevereICU Medical Recalls Stat 2 Flow Controllers Due to High Flow Rate Risk
FDA (Devices) · 2014-10-01
- SevereICU 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
- SevereSymbios Medical Recalls GoPump and GoBlock Kits Due to Flow Control Defects
FDA (Devices) · 2013-06-12
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