Symbios Medical 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.
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, of Indianapolis, Indiana, 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 recall includes Part 510450 Disposable Infusion Pump, Elastomeric Pump 600 mL (10mL/hr), found in the GoBlock Kit 510458 and Disposable Single Infusion Pump. The affected units are distributed nationwide in the United States. The recall covers 33,543 units for all kits. Specific lot numbers for the pumps range from 11-100351 to 12-101243, and the GoBlock Kit 510458 lots range from 11-100618 to 13-100703.
Consumers and healthcare facilities should stop using the affected products and contact Symbios Medical Products for instructions on how to return the items or obtain a replacement.
The recalled product
- Product
- Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found in the following kits GoBlock Kit 510458, Disposable Single Infusion Pump
- Manufacturer
- Symbios Medical Products, LLC
- Category
- Medical Device — Infusion Pump
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 510450
- Lot 11-100351- Lot 12-101243 found in: GoBlock Kit 510458
- Lot 11-100618 to 13-100703
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 Risk
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- 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
- SevereSymbios Recalls GoPump and GoBlock Kits Due to High Flow Rates
FDA (Devices) · 2013-06-12
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