Recall record at a glance
| Official record | Z-0580-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Atrium Medical Corporation |
| Report date | Nov 23, 2016 |
| Recall initiation date | Oct 26, 2016 |
| Quantity | 4836 cases (10/cs) |
| Location | Hudson, NH, United States |
Official product description
Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Why the product was recalled
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Distribution information
Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.
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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