Symbios Recalls GoPump and GoBlock Kits Due to Flow Rate Issues
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 reported functional defects (excessively high flow rates) that pose a risk of harm, but no specific injuries or illnesses are reported in the source text.
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 manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031).
The affected products are disposable infusion pumps used for drug delivery. The recall covers 33,543 kits distributed nationwide in the United States. Specific affected items include Part 510613 Disposable Infusion Pump, Elastomeric Pump 300mL (150 mL side) (6mL/hr), found in GoBlock Kit 510612.
Consumers should stop using the affected kits and contact Symbios Medical Products for further instructions.
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 11-100136- 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
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Same hazard · flow rate defect
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