Z-1453-2013Class I

Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side...

Name: Z-1453-2013 Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side...
Creator: Symbios Medical Products, LLC
Published: 2013-05-10
License: https://open.fda.gov/license/

Symbios Medical Products, LLC / initiated 2013-05-10 / Terminated / root cause: manufacturing process

FDA source

Symbios Medical Products, LLC began a recall of 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... on 2013-05-10. FDA classified it as Class I and 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1453-2013
Classification: Class I
Status: Terminated
Initiated: 2013-05-10
Posted: 2013-06-06
Terminated: 2014-03-07
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.
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: all kits 33,543
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1453-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1452-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1453-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1454-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1455-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1456-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1457-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1458-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1459-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1460-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1461-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06
Z-1462-2013	Class I	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-06

Product code MEB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)