Source: http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=65192&w=06122013&lang=eng
Timestamp: 2016-02-06 19:00:14
Document Index: 712347787

Matched Legal Cases: ['art 510031', 'art 510121', 'art 510121', 'art 510180', 'art 510180', 'art 510076', 'art 510636', 'art 510636', 'art 510613', 'art 510613', 'art 510613', 'art 510490', 'art 510490', 'art 510450', 'art 510450', 'art 510449', 'art 510449']

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 510042 - BP, w/ Epidural Catheter, BIOPATCH
GoPump Kit 510110, w/2.5" Fenestrated Catheter GoPumpKit 510110-BP, w/2.5" Fenestrated Catheter,BioPatch GoPumpKit 510350 w/ Epidural Catheter GoPump Kit 510350-BP w/ Epidural Catheter, BIOPATCH
GoPumpKit 510556-BP , 2.5 catheter, BIOPATCH
Symbios GOPump Rapid Recovery System is a local pain mangagement system that consits of a small balloon that is inflated with a local anesthetic medication. Pump 510031, Lot 11-l 00106 to Lot 12-101133 Kit 510042, lots 11-100251 to 13-100128
Kit 510042-BP , lot 12-101300
Kit 510110, lot 11-100664
Kit 510110-BP, Lots 11-100838 to 12-101560
Kit 510350, Lots 11-100353 to 12-100233
Kit 510350-BP, Lots12-100429 to 13-100047 Kit 510556-BP Lots 11-100779 to 12-101552 Class I
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 300 mL (dual reservoir), 2 mL/hr GOPump (PN510076). To date, there have been 5 complaints received, 2 of which involved serious injury. There have been no patient deaths reported. The risk of patient toxicity due to the rapid influx of medication include seizure, dysrhythmia, and death.
33, 543 in all sizes/ kits
Z-1452-2013
GoPump Kit 64310 Disposable Single Infusion Pump. Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. GoPump Kit 510462-BP, Lot 11-100694- Lot 13-100092
34517 for all kits
Z-1456-2013
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
GoPump Kit 510205BP, 5" Fenestrated catheter & Biopatch
GoPump Kit 510551-BP, 2.5 Fenestrated catheter & Biopatch
GoBlock kit 510608
Disposable Single Infusion Pump; Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. Pump Part 510121, Lot 11-100081 to 12-101406 found in: Go Pump Kit 510203-BP. Lot 12-101301 to 13-101538
GoPump Kit 510204, 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
33,543 in all kits
Z-1455-2013
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 Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered via tubing to the surgical site at a very slow rate
Pump Part 510180, Lot 11-100453 to 12-101003 found in: Go Pump Kit 510201-BP. Lot 12-100108 to 12-101538 Go Pump Kit 510349-BP. Lot 12-100935
Go Pump Kit 510642, Lot 12-100616 to 13-100590
all kits 33, 543
Z-1454-2013
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 510141-BP,10" fenestrated catheter& BIOPATCH
Disposable Single Infusion Pump for drug delivery Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. Pump 510076 Lot 11-100222 to 12-101087 found in: Kit 510080 BP. Lot 11-100215 to 12-100508
Kit 510141-BP Lot 12-100460 to 12-100673 Kit 510112-BP, Lot 11-100839-to 13-100225
all kits 33,543
Z-1453-2013
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 contained infusion system. Pump Part 510636 , Lot 11-100632- Lot 12-101233 found in: GoBlock Kit 510646, Lot 11-100632- Lot 12-101233 Class I
Z-1462-2013
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. Pump Part 510613 , Lot 11-100815 - Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475
33,543 all kits
Z-1461-2013
Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system. Pump Part 510613 , Lot 11-100136- Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475
Z-1460-2013
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
Pump Part 510490, Lot 11-100379- Lot 12-101132 found in: GoBlock Kit 510491, Lot 11-100601 to 13-100705
33, 543 for all kits
Z-1459-2013
Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found in the following kits
GoBlock Kit 510458,
Disposable Single Infusion Pump Pump Part 510450, Lot 11-100351- Lot 12-101243 found in: GoBlock Kit 510458, Lot 11-100618 to 13-100703 Class I
Z-1458-2013
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 inflated with a local anesthetic medication.
Pump Part 510449, Lot 11-100271 - Lot 130100137
found in: GoBlock Kit 510472, Lot 11-100385 to 13-100354 Class I
Z-1457-2013