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
FDA device recall Z-1680-2015 · posted 2015-05-28 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- 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.
- Action taken
- GE Healthcare sent an "Urgent Medical Device Correction" letter GEHC Ref#36111 dated April 24, 2015. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, & Director of Biomedical Engineering, The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. A confirmation form is asked to be returned and GE will replace all affected product. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CCL
- Quantity affected
- 5,018 (US = 2,948 / OUS = 2,070)
- Distribution
- Worldwide Distribution - US Nationwide including Washington DC, Puerto Rico. and the countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colo
- Date initiated
- 2015-04-24
- Date posted
- 2015-05-28
- Date terminated
- 2016-09-07
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC (K051092) | GE Healthcare | 2005-05-25 |