Symbios Medical Products Issues Nationwide Recall of GOPump and GOBlock Kits

Date of Recall
2013-05-16

Recall Details
- 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 [email protected].

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

Recall Comments

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