FDA-Device2014-11-05Class II

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.

Parker Laboratories, Inc.
Hazard

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.

Sold states
Worldwide Distribution: US (Nationwide) and country of: Canada.
Affected count
367 boxes
Manufactured in
286 Eldridge Road, N/A, Fairfield, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0145-2015

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