Recall record at a glance
| Official record | Z-0479-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Report date | Dec 30, 2015 |
| Recall initiation date | Nov 23, 2015 |
| Quantity | 127 |
| Location | Raynham, MA, United States |
Official product description
VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
Why the product was recalled
Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only
Distribution information
Worldwide Distribution - US Distribution to the states of : AL, CA, CT, FL, KY, MN, MS, ND, NJ, NM and TX., and to the countries of: France, Netherlands and Norway.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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