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.
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: "Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents."
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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