—#120078

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.

FDA product code: NKC — Tubing/Tubing With Filter, Insufflation, Laparoscopic
Device class: Class 1
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: All Lots of the Insufflation Tubing Sets are as follows: REF 28-0206 Insufflation Tubing, Laparoscopic, Lot #29074214; REF 28-0214 Hi-Flow Insufflation Tubing Lot #3194170; REF 28-0216 Tubing, Insuf w/.3 Micr Filter Lot #29074249; REF 28-0217 Insufflation Tubing, Laparoscopic Lot #32305010; DeRoyal REF 28-0208 Insufflation Tubing w/Vent Lot #29314302; DeRoyal REF 28-0212H Heated Hi-Flow Insufflation Tubing Lot #29000354.

Why it was recalled

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 (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: 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, Quebec, Canada, Japan, and Ireland.

Timeline

Recall initiated: 2013-07-15
Posted by FDA: 2013-08-28
Terminated: 2015-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120078. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.