CLASS II Device recall · Reported 3 Jun 2015 · FDA Enforcement Report

D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. recalled

GE Healthcare is recalling D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap., distributed nationwide in the US. The recall was initiated on 24 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesp/n 876446-HEL Lot numbers: J9964985, J10201698, J10258248, J10284871, J10284872, J10344108. p/n 881319-HEL Lot numbers: J9906966, J9965152, J10258251, J10300071.

Quantity recalled5,018 (US = 2,948 / OUS = 2,070)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1680-2015
FDA event ID: 71044
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2015
FDA classified: 27 May 2015
Reported: 3 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

24 Apr 2015	Recall initiated by company
27 May 2015	Classified by FDA	+33 days
3 Jun 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. This water trap occlusion could cause a loss of respiratory airway gas monitoring.

Product as listed by the FDA

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 monitoring respiratory parameters. D-fend and D-fend+ water traps are used with Compact gas module E-C(Ai)O(V)(X) and CardioCap/5 monitors. The Datex-Ohmeda S/5 Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patients respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N2O+O2 mixtures. The device is indicated for use by qualified medical personnel only.

Where it was distributed

Worldwide Distribution - US Nationwide including Washington DC, Puerto Rico. and the countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic , Egypt, Estonia, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guernsey , Guernsey , Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Korea (Republic of), Kuwait, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand , Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam,

Nationwide District of Columbia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

p/n 876446-HEL Lot numbers: J9964985, J10201698, J10258248, J10284871, J10284872, J10344108. p/n 881319-HEL Lot numbers: J9906966, J9965152, J10258251, J10300071.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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