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 due to reports of excessively high flow rates.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect causing excessively high flow rates, which poses a risk of harm (over-infusion) to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Symbios Medical Products, LLC, of Indianapolis, Indiana, 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 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 source text does not specify the total number of units affected or the specific distribution locations beyond the general context of the recall.
Consumers and healthcare facilities should stop using the affected GoPump and GoBlock kits immediately. The source text does not provide specific instructions for disposal or return, but users should contact Symbios Medical Products for further guidance.
The recalled product
- Product
- Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
- 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 510613
- Lot 11-100815 - Lot 12-10101060 found in: GoBlock Kit 510612
- Lot 11-100817 to 13-101475
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
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