Z-0940-2013Class I

GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number...

Name: Z-0940-2013 GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number...
Creator: Symbios Medical Products, LLC
Published: 2013-02-25
License: https://open.fda.gov/license/

Symbios Medical Products, LLC / initiated 2013-02-25 / Terminated

FDA source

Symbios Medical Products, LLC began a recall of GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL... on 2013-02-25. FDA classified it as Class I and gives the reason as "Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0940-2013
Classification: Class I
Status: Terminated
Initiated: 2013-02-25
Posted: 2013-03-13
Terminated: 2014-02-13
Recalling firm: Symbios Medical Products, LLC
Product: GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer. The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management
Product code: MEB Pump, Infusion, Elastomeric
Reason for recall: Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.
FDA root cause: Pending
Action: Symbios sent an Urgent Medical Device Recall letter dated February 25, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to follow the enclosed 'Steps for Voluntary Field Action' in their entirety. These steps contain information about: I) identifying the product to be returned, 2) obtaining a Returned Goods Authorization number, and 3) returning the recalled product. If product(s) is (are) located, please call 317-450-0145 from 7:00 a.In '0 5:00 p.m. EDT to receive a Returned Goods Authorization umber ("RGA"). Please indicate the RGA number on the outside of the package. Attached is a Verification Form. Customers were instructed to complete and return the form even if they do not have any product to return. Their local sales representative can assist them in completing this form. Distributors of the affected product were instructed to contact Symbios at the number provided and forward the recall notice to all their affected accounts. For questions regarding this recall call 317-225-4447.
Quantity in commerce: 458
Distribution: Nationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA.
Product codes and lots: Kit Part Number 510545-BP, lot 12-100983, 12-100984, 12-101096, 12-101125 Kit Part Number 510112-BP, lot 12-101110, 12-101103 Kit: 510401-BP lot 12-101045 Kit: 510644, lot 12-101028, 12-101097, 12-101130 GOPump Dual Infusion Pump Kit All Kits contain Pump Part Number: 510076 Lot Number: 12-100601

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0940-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0940-2013	Class I	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-13

Product code MEB

K072921Class IIDisposable Infusion Pump Kit, Go Pump Rapid Recovery SystemSymbios Medical Products, LLC / cleared 2007-11-26

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)