The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1460-2013·Announced 2013-06-12

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.

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, 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 →

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