D-fend — Class II medical device recall Z-1680-2015
Terminated recall by GE Healthcare, reported 2015-06-03, distributed nationwide. A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+
| Recall number | Z-1680-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, Waukesha, WI, United States |
| Recall initiated | 2015-04-24 |
| Classified | 2015-05-27 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2016-09-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IS, IT, JM, JO, JP, KR, KW, LT, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, RU, SA, SE, SG, SI, TH, TR, TW, UA, VN, ZA |
| Reason classes | device malfunction |
| Lot numbers | 881319-HEL, J10201698, J10258248, J10258251, J10284871, J10284872, J10300071, J10344108, J9906966, J9964985, J9965152 |
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 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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.