| ||Class 1 Device Recall GOPump |
||June 06, 2013
||Terminated on March 07, 2014
|Recall Event ID
Pump, infusion, elastomeric -
||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.
||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
Symbios Medical Products, LLC
7301 Georgetown Rd.
|For Additional Information Contact
|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
|Under Investigation by firm
||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
||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.