Reported Jan 7, 2015 · Terminated
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for…
Atricure Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atricure Inc · 6217 Centre Park Drive · West Chester, OH · 45069
Is this the product you have?
- Cryogenic probe for cardiac ablation surgery, packaged individually
- in Tyvek pouches Product UsageCryogenic 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 target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway
- Lot codes and dates
- The following batch
- numbers are affected by this recall
241 of 241 codes
265002783127959282482847228474284752891028911293372946129525297882992629933299343035830359306183081031401314023203732200322103221132771327903304733261332623334033527335283358133582336313366133663339183428334284345863458734793348523485335167351773524735307353083568235683362793629236686370053720737558
- Amount recalled
- 19,190 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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