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U.S. Department of Health and Human Services

Class 1 Device Recall GOPump

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 Class 1 Recall
GOPump
see related information
Date Posted June 06, 2013
Recall Status1 Terminated on March 07, 2014
Recall Number Z-1457-2013
Recall Event ID 65192
Product Classification Pump, Infusion, Elastomeric - Product Code MEB
Product 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.
Code Information Pump Part 510449, Lot 11-100271 - Lot 130100137 found in: GoBlock Kit 510472, Lot 11-100385 to 13-100354
Recalling Firm/
Manufacturer
Symbios Medical Products, LLC
7301 Georgetown Rd.
Suite 150
Indianapolis, Indiana 46268
For Additional Information Contact Tom Cavanaugh
317-225-4447
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Symbios sent UrgentMedical Device Recall notices to all consignees beginning May 10, 2013. A second corrected/amended notice was sent on May 14, 2013 to consignees and a National Press release was issued. May 30,2013, a third amended Urgent Recall Notice was sent to all consignees correcting the pump description and lot number range table on page 5 of the notice. The notices and press release provided identification of the recalled devices including devices in the previous February 2013 recall, described possible adverse events, and included directions to to quarantine product in a secure location, in preparation for return. Consignees were asked to call 317 225-4447 ext. 25, 8:00 a.m to 4:00 p.m. EDT to receive a Returned Goods Authorization Number prior to returning product. Consignees were asked to complete and return the Attached Verification Form. Question and Concerns should be addressed to 317-225-4447 ext 25.
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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