• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall GOPump Elastomeric infusion PumpKit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 1 Recall
GOPump Elastomeric infusion PumpKit
see related information
Date Posted March 13, 2013
Recall Status1 Terminated on February 13, 2014
Recall Number Z-0940-2013
Recall Event ID 64423
Premarket Notification
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/
Manufacturer
Symbios Medical Products, LLC
7301 Georgetown Rd.
Suite 150
Indianapolis, Indiana 46268
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
OTHER/UNDETERMINED: Pending
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 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.
510(K) Database 510(K)s with Product Code = MEB and Original Applicant = SYMBIOS MEDICAL PRODUCTS, LLC
-
-