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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-1452-2013
Recall Event ID 65192
Product Classification Pump, Infusion, Elastomeric - Product Code MEB
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.
Code Information Pump 510031, Lot 11-l 00106 to Lot 12-101133 Kit 510042, lots 11-100251 to 13-100128 Kit 510042-BP , lot 12-101300 Kit 510110, lot 11-100664 Kit 510110-BP, Lots 11-100838 to 12-101560 Kit 510350, Lots 11-100353 to 12-100233 Kit 510350-BP, Lots12-100429 to 13-100047 Kit 510556-BP Lots 11-100779 to 12-101552
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.
Quantity in Commerce 33, 543 in all sizes/ kits
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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