Recall Z-0717-2012 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Impact Instrumentation, Inc.
Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable Ventilator
| Date | Jan 12, 2012 (initiated Oct 19, 2011) |
| Status | Terminated |
| Reason | Model 750 24' MRI Reusable/Disposable Circuit does not have a 510(k). |
| Root cause | PMA |
| Action | Impact sent Urgent Device Product Recall letters/return response forms dated 10/19/11 to their consignees. The letter asked customers to return the affected product listed to the address provided within 10 days of receipt of the notification letter. In order to receive proper credit for the returned product, customers should follow the instructions precisely, which includes completing and returning the Recall Tracking Form along with the affected product. If customers have no product to return, they should contact Alan Giordano at agiordano@impactii.com, to inform him of the status of the c |
| Quantity | 564 units |
| Distribution | Nationwide Distribution -- VA, CA, IL, NC, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.