DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insuff

FDA device recall Z-2113-2013 · posted 2013-08-28 · Terminated

Recall details

Recalling firm

DeRoyal Industries Inc

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.

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

NKC

Quantity affected

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, O

Date initiated

2013-07-15

Date posted

2013-08-28

Date terminated

2015-05-20

Location

Powell, TN