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 PN	From Kit Lot #	To Kit Lot #	Kit description
510042	11-100251	13-100128	GoPump kit 150mL, 2 mL/hr Epidural Catheter
510042-BP	12-101300	12-101300	GoPump kit 150mL, 2 mL/hr, Epidural Catheter & BIOPATCH
510080-BP	11-100215	12-100508	GoPump kit 300mL, 2 mL/hr/side, 5" Fenestrated Catheter and Biopatch
510110	11-100664	11-100664	GoPump kit 150mL, 2 mL/hr 2.5" Fenestrated Catheter
510110-BP	11-100838	12-101560	GoPump kit 150mL, 2 mL/hr 2.5" Fenestrated Catheter and Biopatch
510112-BP	11-100839	13-100225	GoPump kit 300mL, 2 mL/hr/side, 2.5" Fenestrated Catheter & BIOPATCH
510141-BP	12-100460	12-100673	GoPump kit 300mL, 2 mL/hr/side, 10" Fenestrated Catheter & BIOPATCH
510201-BP	12-100108	12-101538	GoPump kit 300mL, 2 ml/hr, 5" Fenestrated Catheter & BIOPATCH
510203-BP	12-101301	13-100611	GoPump kit 300ml, 4 ml/hr, Epidural Cath & BIOPATCH
510204	11-100505	11-100665	GoPump kit 300ml, 4 ml/hr, 2.5" Fenestrated Cath
510204-BP	11-100721	13-100680	GoPump kit 300ml, 4 ml/hr, 2.5" Fenestrated Cath & BIOPATCH
510205-BP	11-100722	13-100087	GoPump kit 300ml, 4 ml/hr, 5" Fenestrated Catheter & BIOPATCH
510349-BP	12-100935	12-100935	GoPump kit 300ml, 2 ml/hr, Epidural Catheter, 2.75" Needle, BIOPATCH
510350	11-100353	12-100233	GoPump kit 150ml, 2 ml/hr, Epidural Catheter, 2.75" Needle
510350-BP	12-100429	13-100047	GoPump kit 150ml, 2 ml/hr, Epidural Catheter, 2.75" Needle, BIOPATCH
510401-BP	12-101045	12-101540	GoPump kit 300mL, 2 mL/hr/side, 7.5" Catheters, BIOPATCH
510458	11-100618	13-100703	GOBlock Kit 600 ml, 10 ml/hr
510462-BP	11-100694	13-100092	GoPump kit 600mL, 2 mL/hr/side, 5" Catheter, BIOPATCH
510472	11-100385	13-100354	GOBlock Kit 600 ml, 8 ml/hr
510491	11-100601	13-100705	GOBlock Kit 600 ml, 6 ml/hr
510545-BP	11-100718	13-100229	GoPump kit 300mL, 2 mL/hr/side, 5" Fenestrated Catheter, BIOPATCH
510551-BP	11-100500	13-100672	GoPump kit 300mL, 4 ml/hr, 2.5" Catheter, 2.75" Needle, BIOPATCH
510556-BP	11-100779	12-101552	GoPump kit 150ml, 2 ml/hr, 2.5" Catheter with 2.75" Needle, BIOPATCH
510558-BP	12-100403	12-101343	GoPump kit 600mL, 2 mL/hr/side, 10" Catheter, 6" needle, BIOPATCH
510608	11-100695	12-101544	GOBlock kit 300mL, 4 ml/hr
510611	11-100302	13-100227	GOBlock Kit 300ml, 4 ml/hr
510612	11-100817	12-101475	GOBlock Kit 300ml, 6 ml/hr
510642	12-100616	13-100590	GoPump kit 300mL, 2 ml/hr
510643	12-100332	13-100183	GoPump kit 600mL, 2 mL/hr/side
510646	11-100632	12-101233	GoPump kit 600mL, SF
510644	11-100565	13-100169	GoPump kit 300mL, 2 ml/hr per side
510654	11-100833	13-100174	GOPump 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:

• Online at http://www.fda.gov/MedWatch/report.htm
• http://www.fda.gov/MedWatch/getforms.htm
  (form available to fax or mail), or
• Call FDA 1-800-FDA-1088

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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