—#106379

Product

STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller (Needle-Free), 12 length, Catalog/REF No. P-S2-12 N, 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.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K964844
Affected lot / code info: Beginning Lot Code 0603241, Ending Lot Code 1103114

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: ConMed Corporation
Address: 525 French Road, Utica, New York 13502

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) - including the countries of: Australia, Barbados, Belgium, Bermuda, Canada, Egypt, Israel, India, Italy, Korea, New Zealand, Philippines and Saudi Arabia.

Timeline

Recall initiated: 2011-04-15
Posted by FDA: 2012-01-11
Terminated: 2012-11-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106379. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.