Recall Z-0582-2017
Atrium Medical Corporation · initiated October 26, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Codes / lots: All lot codes
Reason for recall
Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
FDA-determined cause: Labeling design
Action taken
Atrium Medical issued an "Urgent Medical Device Recall (Removal)" communication to customers on 10/26/16 via FedEx 2 day delivery. The recall identifies the problem, product, and risk factors. In addition, it provides instructions on how to handle product that may be affected. Accounts are to read the letter completely and share with all users and staff. They have been requested to complete the enclosed Recall Reply Form, acknowledging receipt of the notice; and, remove and quarantine any affected product for return. Additionally, obtain product from an alternate supplier because replacement product is not available as all Trocar catheters have been discontinued. Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm, for a Return Goods Authorization to return the product and receive credit.
Details
- Recall number
- Z-0582-2017
- Initiated
- October 26, 2016
- Terminated
- October 9, 2018
- Product code
- GBZ – Catheter, Cholangiography
- Quantity
- 7043 cases (10/cs)
- Distribution
- 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.
- Recalling firm
- Atrium Medical Corporation, Hudson, NH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0576-2017 Class II | Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | 10/26/2016Terminated |
| Z-0577-2017 Class II | Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | 10/26/2016Terminated |
| Z-0578-2017 Class II | Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | 10/26/2016Terminated |
| Z-0579-2017 Class II | Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | 10/26/2016Terminated |
| Z-0580-2017 Class II | Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | 10/26/2016Terminated |
| Z-0581-2017 Class II | Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intended to facilitate…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | 10/26/2016Terminated |
| Z-0583-2017 Class II | Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate…Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the… | 10/26/2016Terminated |