Agency classClass IIOur severity:High FDA (Devices)·Z-2113-2013·Announced 2013-09-04

DeRoyal Recalls Insufflation Tubing Sets Due to Materials Incompatibility

DeRoyal Industries is recalling specific lots of insufflation tubing sets because materials incompatibility could cause occlusion, potentially preventing gas flow during laparoscopic surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a defect could prevent gas flow during surgery, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

DeRoyal Industries is recalling specific lots of Insufflation Tubing Sets used during laparoscopic surgical procedures. The recall is due to materials incompatibility, which could possibly result in occlusion at or near the filter housing. This issue could prevent the flow of gas through the device.

The affected products include six specific reference numbers: 28-0206, 28-0214, 28-0216, 28-0217, 28-0208, and 28-0212H. The recall covers 506,632 sets in the United States and 17,854 sets internationally. Distribution was nationwide in the US and included specific regions in Canada, Japan, Ireland, and the Arab Emirates.

Healthcare providers and patients should check their inventory and patient records for these specific lot numbers. If the affected tubing sets are found, they should be removed from use and returned to DeRoyal Industries or the distributor.

The recalled product

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…
Manufacturer: DeRoyal Industries Inc
Category: Medical Device — Surgical Tubing
Hazard: device-malfunction
occlusion

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

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.

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

Same manufacturer · DeRoyal Industries Inc

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