GE Healthcare Recalls D-Fend Water Traps Due to Occlusion Risk
GE Healthcare is recalling D-Fend and D-Fend+ water traps because they may occlude, causing a loss of respiratory gas monitoring.
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 is classified as FDA Class II and involves a risk-of-harm product (loss of monitoring) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GE Healthcare is recalling specific D-Fend and D-Fend+ water traps used with Compact Airway Modules and Cardiocap/5 monitors. The recall involves 5,018 units distributed worldwide, including the United States and numerous international locations.
The recall is due to a potential safety issue where the water traps may occlude. This occlusion can cause a loss of respiratory airway gas monitoring, which is intended to protect the monitor from humidity, secretions, and bacterial contamination while monitoring patient respiration and ventilation.
Healthcare facilities should identify the affected units by checking the product numbers (876446-HEL and 881319-HEL) and specific lot numbers listed in the recall notice. Affected units should be removed from service and returned to GE Healthcare for evaluation or replacement.
The recalled product
- Product
- D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitor
- Manufacturer
- GE Healthcare
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)
- p/n 876446-HEL Lot numbers: J9964985
- J10201698
- J10258248
- J10284871
- J10284872
- J10344108. p/n 881319-HEL Lot numbers: J9906966
- J9965152
- J10258251
- J10300071.
Distribution
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