Recall Z-2113-2013— DeRoyal Industries Inc
Class II · Terminated
Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2013-07-15, terminated 2015-05-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 surgical procedures to aid in the insufflation of the abdomen.. 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..
- Recalling firm
- DeRoyal Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-15
- Terminated
- 2015-05-20
- Firm location
- Powell, TN, United States
Product description
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 surgical procedures to aid in the insufflation of the abdomen.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.