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.
This recall has been terminated (originally issued October 29, 2014).
- Company
- Parker Laboratories, Inc.
- Recall Initiated
- August 6, 2014
- Posted
- October 29, 2014
- Terminated
- April 29, 2015
- Recall Number
- Z-0145-2015
- Quantity
- 367 boxes
- Firm Location
- Fairfield, NJ
- Official Source
- View on FDA website ↗
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
Worldwide Distribution: US (Nationwide) and country of: Canada.
Lot / Code Info
Lot #D424, Part Number PM-038-0224E and BA-046-3801D 4/27/10
Root Cause
Incorrect or no expiration date
Action Taken
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.
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