The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1459-2013·Announced 2013-06-12

Symbios Medical 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 GoPump Rapid Recovery System kits and all GoBlock kits. The recall includes units manufactured with flow control components assembled prior to July 2012. The affected products include the Part 510490 Disposable Infusion Pump and the 2 mL/hr GoPump (PN510031) with a 150 mL reservoir.

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. The recall covers 33,543 units for all kits, which were distributed nationwide in the United States. Affected lot numbers include Pump Part 510490, Lot 11-100379 to Lot 12-101132, and GoBlock Kit 510491, Lot 11-100601 to 13-100705.

Consumers and healthcare facilities should stop using the affected products and contact Symbios Medical Products for further instructions or a replacement.

The recalled product

Product
Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 510491, Disposable Single Infusion Pump for drug delivery
Manufacturer
Symbios Medical Products, LLC
Category
Medical Device — Infusion Pumps
Hazard

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 510490
  • Lot 11-100379- Lot 12-101132 found in: GoBlock Kit 510491
  • Lot 11-100601 to 13-100705

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

Same manufacturer · Symbios Medical Products, LLC

See all →

Same hazard · excessive flow rate

See all →

Similar recalls