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.
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 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…
- 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 →- SevereSymbios Recalls GoPump Rapid Recovery System Kits Due to Flow Rate Issues
FDA (Devices) · 2013-06-12
- SevereSymbios Medical Recalls GoPump and GoBlock 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
- 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 Flow Rate Issues
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 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
- SevereSymbios Medical Recalls GoPump and GoBlock Kits Due to Flow Control Defects
FDA (Devices) · 2013-06-12
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