Recall Z-0686-2012 ยท FPA Set, Administration, Intravascular
ConMed Corporation
STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller (Needle-Free), 20 Drops/cc, 84" length, Catalog/REF No. P-S2V-20 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 a
| Date | Jan 11, 2012 (initiated Apr 15, 2011) |
| Status | Terminated |
| Reason | 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 | 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 th |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964844 | CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS Conmedcorp, Mar 24, 1997 |