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.
What this means for you
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 Insu
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Tubing
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
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