FDA (Devices) recall action 65192

Symbios Medical Products, LLC recalled 11 products on 2013-06-12

The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2013-06-12
Critical: 2
Units: 202,232

Why these products were recalled

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. 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), and the

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–11 of 11

SevereFDA (Devices)··2013-06-12
Symbios Recalls GoPump Rapid Recovery System Kits Due to Flow Rate Issues
Symbios Medical Products is voluntarily recalling GoPump Rapid Recovery System kits because some units may deliver medication at excessively high flow rates.
Product
Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 Disposable Single Infusion Pump, Symbios GOPump…
Category
Distribution
0 states
SevereFDA (Devices)··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.
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
Category
Distribution
0 states
SevereFDA (Devices)··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 before July 2012 due to flow control components that may cause excessively high flow rates.
Product
Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the following kits GoBlock Kit 510472, Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is…
Category
Distribution
0 states
SevereFDA (Devices)··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.
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…
Category
Distribution
0 states
CriticalFDA (Devices)··2013-06-12
Symbios Recalls GoPump and GoBlock Kits Due to High Flow Rates
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 because they may deliver excessively high flow rates.
Product
Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits: GoBlock Kit 510646, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self…
Category
Distribution
0 states
SevereFDA (Devices)··2013-06-12
Symbios Recalls GoPump Rapid Recovery System Kits Due to Flow Control Defect
Symbios Medical Products is voluntarily recalling GoPump Rapid Recovery System kits and GoBlock kits manufactured before July 2012 due to reports of excessively high flow rates.
Product
Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile, found in the following kits: GoPump kit 510080-BP, 5 fenestrated catheter & BIOPATCH; GoPump kit 510112-BP, 2.5" fenestrated catheter & BIOPATCH Go Pump Kit…
Category
Distribution
0 states
CriticalFDA (Devices)··2013-06-12
Symbios Recalls GoPump Rapid Recovery System Kits Due to Flow Rate Issues
Symbios Medical Products is voluntarily recalling GoPump kits because some units may deliver excessively high flow rates.
Product
Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " catheter & BIOPATCH GoPump Kit 510558-BP 10 " catheter& BIOPATCH GoPump Kit 64310 Disposable Single Infusion Pump. Symbios GOPump…
Category
Distribution
0 states
SevereFDA (Devices)··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.
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.
Category
Distribution
0 states
SevereFDA (Devices)··2013-06-12
Symbios Medical 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.
Product
Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found in the following kits GoBlock Kit 510458, Disposable Single Infusion Pump
Category
Distribution
0 states
SevereFDA (Devices)··2013-06-12
Symbios Recalls GoPump and GoBlock Kits Due to High Flow Rates
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 due to reports of excessively high flow rates.
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.
Category
Distribution
0 states
SevereFDA (Devices)··2013-06-12
Symbios Recalls GoPump Infusion Pumps Due to High Flow Rates
Symbios Medical Products is voluntarily recalling GoPump infusion pumps and kits due to reports of excessively high flow rates.
Product
Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO... found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit…
Category
Distribution
0 states