Device product
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.
Z-0145-2015
Product summary
- Event
- Event 69224
- Status
- Terminated
- Classification
- Class II
- Quantity
- 367 boxes
- Official record key
device-enforcement:Z-0145-2015
Official wording
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.
Code information: Lot #D424, Part Number PM-038-0224E and BA-046-3801D 4/27/10
Distribution pattern: Worldwide Distribution: US (Nationwide) and country of: Canada.
Derived failure modes
-
Unknown
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.