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

August 06, 2014

Class II

Product summary

Firm: Parker Laboratories, Inc.
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
reason.no_named_rule · v1.0.0

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.