Symbios Disposable Infusion Pumps Class I

Company:Symbios Medical Products.
Date of Enforcement Report 6/12/2013
Class I:

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/ 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.
Recall Number Z-1452-2013

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. Recall Number Z-1453-2013

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 Recall Number Z-1454-2013

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.
Recall Number Z-1455-2013

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.
Recall Number Z-1456-2013

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.
Recall Number Z-1457-2013

Part 510450 Disposable Infusion Pump, …Elastomeric Pump 600 mL( 10mL/hr ),… found in the following kits GoBlock Kit 510458, Disposable Single Infusion Pump
Recall Number Z-1458-2013

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 Recall Number Z-1459-2013

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. Recall Number Z-1460-2013

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. Recall Number Z-1461-2013

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. Recall Number Z-1462-2013

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 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.

RECALLING FIRM/MANUFACTURER
Symbios Medical Products, LLC Indianapolis , IN on 5/10/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
33, 543 for all kits

DISTRIBUTION
Nationwide

___________________________________

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.