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U.S. Department of Health and Human Services

Class 2 Device Recall STAT 2 Primary Administration Set Gravity Flow Controller,

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 Class 2 Recall
STAT 2 Primary Administration Set Gravity Flow Controller,
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on January 15, 2013
Recall Number Z-0635-2012
Recall Event ID 60702
Premarket Notification
510(K) Number
K964844 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product STAT 2 Primary Administration Set Gravity Flow Controller, 60 Drops/cc, 84 in. length, Catalog/REF No. S2V-60, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device with a sterile, nonpyrogenic fluid path. The STAT 2® Secondary and Primary Administration Sets are for use in attachment to an I.V. bag and patient catheter inserted into a vein to control the infusion of intravenous fluids into the human body.
Code Information Beginning Lot Code 1006284, Ending Lot Code 1103104
Recalling Firm/
Manufacturer
ConMed Corporation
525 French Road
Utica, New York 13502
For Additional Information Contact M. Patricia Cotter
315-624-3533
Manufacturer Reason
for Recall
ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action ConMed Corporation sent Urgent Medical Device Recall Letters and Response Forms dated April 14, 2011, via UPS Priority Mail pouches to all domestic consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The international consignees were sent Urgent Medical Device Recall Letters and Response Forms dated April 22, 2011, via FedEx International Priority. Users were instructed to immediately stop use of the device and return it to ConMed Corporation. --- RECALL EXPANSION: Consignees were also instructed to contact all of those organization within their facility and any other facilities that they may have supplied or given these affected products to. ConMed Corp. sent out Amended Urgent Medical Device Recall Letters and Response Forms dated May 10, 2011, to the 4 consignees via UPS PriorIty Mail for the expansion of the recall for Catalog No. S2-12N, Lot 1006234. For any questions call 315-624-3237 or email ivcontroller@conmed.com.
Distribution Worldwide Distribution - USA (nationwide) and the countries of Canada, Panama and India
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 = FPA and Original Applicant = CONMED CORP.
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