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U.S. Department of Health and Human Services

Class 2 Device Recall STAT 2 Pumpette

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 Class 2 Recall
STAT 2 Pumpette
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on November 20, 2012
Recall Number Z-0687-2012
Recall Event ID 60703
Premarket Notification
510(K) Number
K964844 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product STAT 2 Pumpette® Primary Administration Set Gravity Flow Compensating Controller, 60 Drops/cc, 84" length, Catalog/REF No. P-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. Product Usage: The STAT 2 Pumpette® Extension sets are for use in conjunction with commonly available I.V. administration sets for controlling the infusion of I.V. fluids into the human body. The STAT 2 Pumpette® 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. This is a disposable device with a sterile, nonpyrogenic fluid path.
Code Information Beginning Lot Code 0603241, Ending Lot Code 0811031
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 16 complaints for STAT 2 Pumpette¿ devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette¿ Compensating Controller on several complaint samples had been assembled incorrectly.
FDA Determined
Cause 2
DESIGN: Device Design
Action ConMed sent an "Urgent Medical Device Recall" letters and Reply Forms dated April 15, 2011 to the domestic consignees via UPS Priority Mail pouches and to the foreign consignees via FedEx International Priority. The letter identified the product, description of problem, and actions to be taken. Consignees were instructed to review their inventory and immediately stop use of the affected devices and return them to ConMed Corporation. Consignees who had distributed the affected products outside of their facility were instructed to immediately notify their customers of the recall and provide them with a copy of this notice. Consignees were asked to complete and return the enclosed Reply Form. For questions call 315-624-3237 or email ivcontroller@conmed.com.
Quantity in Commerce 1,146,741 sets in total
Distribution Worldwide Distribution - USA (nationwide) - including the countries of: Australia, Barbados, Belgium, Bermuda, Canada, Egypt, Israel, India, Italy, Korea, New Zealand, Philippines and Saudi Arabia.
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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