Reported Sep 4, 2013 · Terminated
DeRoyal Insufflation Tubing sets
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
DeRoyal Insufflation Tubing sets
6 of 6 products
| Model / number | Product as published |
|---|---|
28-0206 | Insufflation Tubing, Laparoscopic Rx Only |
28-0214 | Hi-Flow Insufflation Tubing Rx Only |
28-0216 | Tubing, Insuf w/.3 Micr Filter Rx Only |
28-0217 | Insufflation Tubing, Laparoscopic Rx Only |
28-0208 | Insufflation Tubing w/Vent Rx Only |
28-0212H | Heated Hi-Flow Insufflation Tubing Rx Only. Used during laparoscopic surgical procedures to aid in the insufflation of the abdomen. |
- Amount recalled
- 506,632 sets in US; 17,854 sets International
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new DeRoyal Industries Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.