Recall Z-2113-2013 ยท NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic
DeRoyal Industries Inc
DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208 Insufflation Tubing w/Vent Rx Only 6) REF 28-0212H Heated Hi-Flow Insufflation Tubing Rx Only. Used during laparoscopic surgica
| Date | Aug 28, 2013 (initiated Jul 15, 2013) |
| Status | Terminated |
| Reason | DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which could prevent the flow of gas through the device. |
| Root cause | Packaging process control |
| Action | The firm notified customers via letters dated 7/15/2013 sent UPS and via DeRoyal Representatives. Customers were asked to notify DeRoyal of any remaining inventory to return for replacement product or credit. Non-responders will receive additional notifications. Effectiveness checks will be performed by contacting non-responders by phone. |
| Quantity | 506,632 sets in US; 17,854 sets International |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and the countries of Dubai, Arab Emirates, Quebe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.