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U.S. Department of Health and Human Services

Class 1 Device Recall GOPump Elastomeric infusion PumpKit

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  Class 1 Device Recall GOPump Elastomeric infusion PumpKit see related information
Date Initiated by Firm February 25, 2013
Date Posted March 13, 2013
Recall Status1 Terminated 3 on February 13, 2014
Recall Number Z-0940-2013
Recall Event ID 64423
510(K)Number K072921  
Product Classification Pump, infusion, elastomeric - Product Code MEB
Product GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer.

The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management
Code Information Kit Part Number 510545-BP, lot 12-100983, 12-100984, 12-101096, 12-101125  Kit Part Number 510112-BP, lot 12-101110, 12-101103  Kit: 510401-BP lot 12-101045  Kit: 510644, lot 12-101028, 12-101097, 12-101130 GOPump Dual Infusion Pump Kit  All Kits contain Pump Part Number: 510076 Lot Number: 12-100601
Recalling Firm/
Symbios Medical Products, LLC
7301 Georgetown Rd.
Suite 150
Indianapolis IN 46268
For Additional Information Contact
Manufacturer Reason
for Recall
Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.
FDA Determined
Cause 2
Action Symbios sent an Urgent Medical Device Recall letter dated February 25, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to follow the enclosed 'Steps for Voluntary Field Action' in their entirety. These steps contain information about: I) identifying the product to be returned, 2) obtaining a Returned Goods Authorization number, and 3) returning the recalled product. If product(s) is (are) located, please call 317-450-0145 from 7:00 a.In '0 5:00 p.m. EDT to receive a Returned Goods Authorization umber ("RGA"). Please indicate the RGA number on the outside of the package. Attached is a Verification Form. Customers were instructed to complete and return the form even if they do not have any product to return. Their local sales representative can assist them in completing this form. Distributors of the affected product were instructed to contact Symbios at the number provided and forward the recall notice to all their affected accounts. For questions regarding this recall call 317-225-4447.
Quantity in Commerce 458
Distribution Nationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MEB and Original Applicant = SYMBIOS MEDICAL PRODUCTS, LLC