Recalls / —

—#106339

Product

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

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 1006284, Ending Lot Code 1103294

Why it was recalled

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.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm

ConMed Corporation

Address

525 French Road, Utica, New York 13502

Distribution

Distribution pattern

Worldwide Distribution - USA (nationwide) and the countries of Canada, Panama and India

Timeline

Recall initiated

2011-04-15

Posted by FDA

2012-01-11

Terminated

2013-01-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #106339. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.