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FDANovember 21, 2014device

Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.

What to do

FDA enforcement status: Terminated

Brands named

atricure

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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