Symbios GOPump Elastometric Infusion PumpKit Recalled for Flow Restrictor Displacement
Symbios Medical Products is recalling 458 GOPump Elastometric Infusion PumpKits because a flow restrictor bead may become displaced, permitting fast flow of contents.
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 defect that permits fast flow of contents, representing a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Symbios Medical Products, LLC is recalling 458 units of the GOPump Elastometric Infusion PumpKit, part number 510076. This medical device is a disposable, self-contained infusion system designed for post-operative pain management. The kit consists of two 150 mL elastomeric reservoirs, each connected to its own catheter, with a labeled liquid flow rate of 2 mL/hr per elastomer.
The recall was initiated after the company received two complaints regarding the affected lot. In both instances, the flow restrictor bead became displaced, which permitted the fast flow of the infusion contents. This defect poses a risk of delivering the prescribed solution at a rate higher than intended.
The affected units were distributed nationwide, including in Pennsylvania, California, Ohio, Alabama, Florida, West Virginia, Tennessee, New Jersey, North Carolina, Texas, Colorado, New York, Missouri, Mississippi, South Carolina, and Georgia. Specific lot numbers and kit part numbers are listed in the agency's structured data. Consumers and healthcare providers should stop using these devices and contact Symbios Medical Products for instructions on return or replacement.
The recalled product
- Product
- GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer.
- Manufacturer
- Symbios Medical Products, LLC
- Category
- Medical Device — Infusion Pump
- Affected units
- 458
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 (9)
- Kit Part Number 510545-BP
- lot 12-100983
- 12-100984
- 12-101096
- 12-101125 Kit Part Number 510112-BP
- lot 12-101110
- 12-101103 Kit: 510401-BP lot 12-101045 Kit: 510644
- lot 12-101028
- 12-101097
Distribution
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