Symbios Recalls GoPump and GoBlock Kits Due to High Flow Rates
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 because they may deliver 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I, which mandates a Critical severity score per the rubric.
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. The recall specifically targets units manufactured with flow control components assembled prior to July 2012. The company is expanding the recall after receiving additional reports of excessively high flow rates on the 150 mL reservoir, 2 mL/hr GoPump (PN510031).
The recalled products include the Part 510636 Disposable Infusion Pump and the GoBlock Kit 510646. These are disposable, self-contained infusion systems used for drug delivery. The affected units were distributed nationwide in the United States.
Consumers and healthcare facilities should stop using the affected GoPump and GoBlock kits immediately. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits: GoBlock Kit 510646, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self…
- 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 (3)
- Pump Part 510636
- Lot 11-100632- Lot 12-101233 found in: GoBlock Kit 510646
- Lot 11-100632- Lot 12-101233
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
- SevereSymbios Recalls GoPump Infusion Pumps Due to High Flow Rates
FDA (Devices) · 2013-06-12
- SevereSymbios Recalls GoPump and GoBlock Kits Due to Flow Rate Issues
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
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
- SevereSymbios Medical Recalls GoPump and GoBlock Kits Due to Flow Control Defects
FDA (Devices) · 2013-06-12
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