FDA Medical Device Recalls (openFDA)
Symbios Medical Products, LLC: 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.
- Recall number
- Z-1453-2013
- Recalling firm
- Symbios Medical Products, LLC
- 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 a local anesthetic medication.
- Status
- Terminated
- Initiated
- 2013-05-10
- Posted
- 2013-06-06
- Terminated
- 2014-03-07
- Reason
- 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
- Root cause
- Under Investigation by firm
- Action
- Symbios sent UrgentMedical Device Recall notices to all consignees beginning May 10, 2013. A second corrected/amended notice was sent on May 14, 2013 to consignees and a National Press release was issued. May 30,2013, a third amended Urgent Recall Notice was sent to all consignees correcting the pump description and lot number range table on page 5 of the notice. The notices and press release provided identification of the recalled devices including devices in the previous February 2013 recall, described possible adverse events, and included directions to to quarantine product in a secure location, in preparation for return. Consignees were asked to call 317 225-4447 ext. 25, 8:00 a.m to 4:00 p.m. EDT to receive a Returned Goods Authorization Number prior to returning product. Consignees were asked to complete and return the Attached Verification Form. Question and Concerns should be addressed to 317-225-4447 ext 25.
- Quantity
- all kits 33,543
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MEB
- Firm FEI
- 3005203102
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28