Recall Z-1987-2013 ยท KDQ Bottle, Collection, Vacuum
Atrium Medical Corporation
PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.
| Date | Aug 20, 2013 (initiated Jul 16, 2013) |
| Status | Terminated |
| Reason | Individual component's IFUs are not included with the kit. |
| Root cause | Labeling Change Control |
| Action | Notice of correction was sent on July 18, 2013 via UPS and e-mail to the field representatives that represent these accounts. The notification identifies the problem, product, and risk factors. It provides instructions how to handle the product that may be affected. Additional labeling will be added to the kit to include instructions for use for the additional components. Atrium Medical will confirm through tracking of the UPS letters that each consignee has received the letter of correction. This shall be 100%. Where a UPS delivery cannot be confirmed, Atrium Medical will make good faith e |
| Quantity | 6,516 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.