Recall Z-1913-2021 ยท ITX Transducer, Ultrasonic, Diagnostic
Exact Medical Manufacturing, Inc.
Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
| Date | Apr 29, 2021 |
| Status | Terminated |
| Reason | No 510k for the product to be used in a natural or surgical opening to the body |
| Root cause | No Marketing Application |
| Action | Exact Medical issued Correction Notification via email on 4/29/21. Letter states: Exact Medical Manufacturing Ultrasonic Transducer Cover can be used to minimize contamination between patient and ultrasound probe during ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not to be used in a natural or surgical opening to the body. The Exact Medical Manufacturing Ultrasonic Transducer Cover are also sold as bulk non-sterile, single use items, to repackers/relabelers establishments for further packaging an |
| Quantity | 5621 units |
| Distribution | US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.