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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Symbios Medical Products Issues Nationwide Recall of GOPump and GOBlock Kits

 

Contact
Consumer:
317-225-4447 ext 25
jcarty@symbiosmedical.com

 

FOR IMMEDIATE RELEASE - May 10, 2013 - Symbios Medical Products initiated a voluntary recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012. These products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.g., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age. To date, there have been 5 complaints received, 2 of which involved serious consequences. There have been no patient deaths reported. The root cause is understood and processes have been put in place to address the issue.

This recall affects only the fifty (50) United States plus the District of Columbia. Distributors and clinical provider sites using these Symbios Medical Products have been notified of the affected product codes and lot numbers. Symbios is working to secure all affected product and have it returned. Products subject to this recall were distributed between April 1st, 2011 and April 30th, 2013. Recall action was begun immediately upon the knowledge of the product related issues.

GOPUMP / GOBLOCK KITS SUBJECT TO RECALL

 Range of Affected Kit Lot #'s 
Kit PNFrom Kit Lot #To Kit Lot #Kit description
51004211-10025113-100128GoPump kit 150mL, 2 mL/hr Epidural Catheter
510042-BP12-10130012-101300GoPump kit 150mL, 2 mL/hr, Epidural Catheter & BIOPATCH
510080-BP11-10021512-100508GoPump kit 300mL, 2 mL/hr/side, 5" Fenestrated Catheter and Biopatch
51011011-10066411-100664GoPump kit 150mL, 2 mL/hr 2.5" Fenestrated Catheter
510110-BP11-10083812-101560GoPump kit 150mL, 2 mL/hr 2.5" Fenestrated Catheter and Biopatch
510112-BP11-10083913-100225GoPump kit 300mL, 2 mL/hr/side, 2.5" Fenestrated Catheter & BIOPATCH
510141-BP12-10046012-100673GoPump kit 300mL, 2 mL/hr/side, 10" Fenestrated Catheter & BIOPATCH
510201-BP12-10010812-101538GoPump kit 300mL, 2 ml/hr, 5" Fenestrated Catheter & BIOPATCH
510203-BP12-10130113-100611GoPump kit 300ml, 4 ml/hr, Epidural Cath & BIOPATCH
51020411-10050511-100665GoPump kit 300ml, 4 ml/hr, 2.5" Fenestrated Cath
510204-BP11-10072113-100680GoPump kit 300ml, 4 ml/hr, 2.5" Fenestrated Cath & BIOPATCH
510205-BP11-10072213-100087GoPump kit 300ml, 4 ml/hr, 5" Fenestrated Catheter & BIOPATCH
510349-BP12-10093512-100935GoPump kit 300ml, 2 ml/hr, Epidural Catheter, 2.75" Needle, BIOPATCH
51035011-10035312-100233GoPump kit 150ml, 2 ml/hr, Epidural Catheter, 2.75" Needle
510350-BP12-10042913-100047GoPump kit 150ml, 2 ml/hr, Epidural Catheter, 2.75" Needle, BIOPATCH
510401-BP12-10104512-101540GoPump kit 300mL, 2 mL/hr/side, 7.5" Catheters, BIOPATCH
51045811-10061813-100703GOBlock Kit 600 ml, 10 ml/hr
510462-BP11-10069413-100092GoPump kit 600mL, 2 mL/hr/side, 5" Catheter, BIOPATCH
51047211-10038513-100354GOBlock Kit 600 ml, 8 ml/hr
51049111-10060113-100705GOBlock Kit 600 ml, 6 ml/hr
510545-BP11-10071813-100229GoPump kit 300mL, 2 mL/hr/side, 5" Fenestrated Catheter, BIOPATCH
510551-BP11-10050013-100672GoPump kit 300mL, 4 ml/hr, 2.5" Catheter, 2.75" Needle, BIOPATCH
510556-BP11-10077912-101552GoPump kit 150ml, 2 ml/hr, 2.5" Catheter with 2.75" Needle, BIOPATCH
510558-BP12-10040312-101343GoPump kit 600mL, 2 mL/hr/side, 10" Catheter, 6" needle, BIOPATCH
51060811-10069512-101544GOBlock kit 300mL, 4 ml/hr
51061111-10030213-100227GOBlock Kit 300ml, 4 ml/hr
51061211-10081712-101475GOBlock Kit 300ml, 6 ml/hr
51064212-10061613-100590GoPump kit 300mL, 2 ml/hr
51064312-10033213-100183GoPump kit 600mL, 2 mL/hr/side
51064611-10063212-101233GoPump kit 600mL, SF
51064411-10056513-100169GoPump kit 300mL, 2 ml/hr per side
51065411-10083313-100174GOPump kit 150mL, 2 ml/hr

Consumers or using customer sites with questions may contact the company via telephone at 317-225-4447 ext 25 between the hours of 8:00am and 4:00pm.EST. Customers may also contact the company via e-mail at jcarty@symbiosmedical.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:

Symbios Medical Products is committed to the highest level of product quality and fully regrets the most recent product related issues. The Board of Directors of Symbios and its Management Team are constantly reviewing our programs and processes for product requirements and quality of our product in support of pain control of our customer’s patients. The expanse of this action is indicative of our desire to insure safe and effective product availability.

Symbios Medical Products
7301 Georgetown Road Suite 150
Indianapolis, Indiana 46268 317‐225‐4447 Ext 25
www.symbiosmedical.com

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