Recall Z-0145-2015 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Parker Laboratories, Inc.
Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.
| Date | Oct 29, 2014 (initiated Aug 6, 2014) |
| Status | Terminated |
| Reason | Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the Eclipse Probe Covers. |
| Root cause | Incorrect or no expiration date |
| Action | Parker Laboratories Inc. sent an "Urgent Medical Device Product Recall" Letter/Response Form via Fedex to their customers. The letter indentified the affected product, problem and actions to be taken. For questions contact Parker Laboratories Quality Assurance at 973-276-9500, ext. 7142. |
| Quantity | 367 boxes |
| Distribution | Worldwide Distribution: US (Nationwide) and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953673 | ECLIPSE PROBE COVER Parker Laboratories, Inc., Mar 14, 1996 |