Symbios Medical Products, LLC: 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

Agency Publication Date: June 6, 2013

Affected Products

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 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/ E

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

Lot Numbers:

11-l

12-101133

12-101300

11-100664

s12-100429

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 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

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

Lot Numbers:

11-100222

11-100215

12-100460

11-100839-to

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 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 ra

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

Lot Numbers:

11-100453

12-100108

12-100935

12-100616

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 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 man

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 GoBlock kit 510608

Lot Numbers:

11-100081

12-101301

11-100505

11-100721

11-100722

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 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 GoPump Kit 510558-BP , Lot 12-100230 - Lot12-101343 GoPump Kit 510643, Lot 12-100332 - Lot 13-100183

Lot Numbers:

11-100694-

13-100092

12-100230

12-101343

12-100332

13-100183

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 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

Lot Numbers:

11-100271

130100137

11-100385

Product: 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

Lot Numbers:

11-100351-

12-101243

11-100618

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

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

Lot Numbers:

11-100379-

12-101132

11-100601

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.

Pump Part 510613 , Lot 11-100136- Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475

Lot Numbers:

11-100136-

12-10101060

11-100817

Pump Part 510613 , Lot 11-100815 - Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475

Lot Numbers:

11-100815

12-10101060

11-100817

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 contained infusion system.

Pump Part 510636 , Lot 11-100632- Lot 12-101233 found in: GoBlock Kit 510646, Lot 11-100632- Lot 12-101233

Lot Numbers:

11-100632-

12-101233

11-100632-

12-101233

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65192

Status: Resolved

Manufacturer: Symbios Medical Products, LLC

Manufactured In: United States

Units Affected: 10 products (33, 543 in all sizes/ kits; all kits 33,543; all kits 33, 543; 33,543 in all kits; 34517 for all kits; 33, 543 for all kits; 33, 543 for all kits; 33,543 all kits; 33,543 all kits; 33543)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot Numbers:

11-l

12-101133

12-101300

11-100664

s12-100429

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

Lot Numbers:

11-100222

11-100215

12-100460

11-100839-to

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

Lot Numbers:

11-100453

12-100108

12-100935

12-100616

Lot Numbers:

11-100081

12-101301

11-100505

11-100721

11-100722

GoPump Kit 510462-BP, Lot 11-100694- Lot 13-100092 GoPump Kit 510558-BP , Lot 12-100230 - Lot12-101343 GoPump Kit 510643, Lot 12-100332 - Lot 13-100183

Lot Numbers:

11-100694-

13-100092

12-100230

12-101343

12-100332

13-100183

Pump Part 510449, Lot 11-100271 - Lot 130100137 found in: GoBlock Kit 510472, Lot 11-100385 to 13-100354

Lot Numbers:

11-100271

130100137

11-100385

Product: 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

Lot Numbers:

11-100351-

12-101243

11-100618

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

Lot Numbers:

11-100379-

12-101132

11-100601

Pump Part 510613 , Lot 11-100136- Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475

Lot Numbers:

11-100136-

12-10101060

11-100817

Pump Part 510613 , Lot 11-100815 - Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475

Lot Numbers:

11-100815

12-10101060

11-100817

Pump Part 510636 , Lot 11-100632- Lot 12-101233 found in: GoBlock Kit 510646, Lot 11-100632- Lot 12-101233

Lot Numbers:

11-100632-

12-101233

11-100632-

12-101233

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65192

Status: Resolved

Manufacturer: Symbios Medical Products, LLC

Manufactured In: United States