Z-0145-2015 Class II Terminated
FDA device recall Z-0145-2015 was initiated by Parker Laboratories, Inc. on August 6, 2014 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated April 29, 2015). Affected quantity: 367 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- November 5, 2014
- Initiation Date
- August 6, 2014
- Termination Date
- April 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 367 boxes
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and country of: Canada.
Code Information
Lot #D424, Part Number PM-038-0224E and BA-046-3801D 4/27/10