The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1455-2013·Announced 2013-06-12

Symbios Recalls GoPump and GoBlock Kits Due to Flow Control Defects

Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured with flow control components assembled prior to July 2012 due to reports of 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 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: "Symbios Medical Products, 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.…"

Plain-English summary

Symbios Medical Products, LLC is voluntarily recalling all GoPumps found in 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 the company received additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031).

The affected products include the Part 510121 Disposable Infusion Pump (Elastomeric Pump 300 mL, 4mL/hr) found in various GoPump and GoBlock kits. The recall covers 33,543 units in all kits distributed nationwide in the United States. Specific lot numbers for the pump and kits are listed in the agency's structured data.

Consumers and healthcare providers should stop using the affected kits and contact Symbios Medical Products for further instructions. The recall is voluntary and is being conducted by the manufacturer in Indianapolis, Indiana.

The recalled product

Product
Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits GoPump Kit 510203-BP, Epidural catheter & BIOPATCH GoPump Kit 510204, 2.5" Fenestrated catheter GoPump Kit 510204 BP, 2.5 Fenestrated catheter & Biopatch…
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 (4)

  • Pump Part 510121
  • Lot 11-100505 to 11-1-665 GoPump Kit 510204 BP
  • Lot 11-100721 to 13-100680 GoPump Kit 510205BP
  • Lot 11-100722 to 13-100087 GoBlock kit 510608

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 →

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