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D-fend/D-fend+ Urgent Medical Device Correction

April 29, 2015

Dear Valued Customer,

 

Biomed Technologies has recently been made aware by GE Healthcare of 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 manufacturer recall effects specific manufacturing LOT numbers. Your facility may have purchased D-Fend / D-Fend+ Water Traps manufactured by GE Healthcare from other sources. Please also be aware that GE Healthcare / Datex-Ohmeda has licensed the D-Fend Water Traps to a few other manufacturers. In this case, the packaging would still be labeled as “D-Fend”, but possibly with another manufacturers name.

 

Biomed Technologies commonly sells D-Fend Water Traps as Part Numbers 123-129 and 122-043. We have not sold D-Fend+ Water Traps manufactured by GE Healthcare.

 

Your facility may or may not have received the URGENT FIELD SAFETY NOTICE. Please review the notice CLICK HERE with its Affected Product Details & Safety Instructions and ensure that all potential users in your facility are made aware of this safety notification along with the recommended actions.

 

Should you have any questions, please contact GE Healthcare Service at (800) 437-1171.

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