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.
FDA Recall Z-0145-2015 · Posted 2014-10-29
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Recalling FirmParker Laboratories, Inc.
Recall StatusTerminated
Product CodeIYO
Date Initiated2014-08-06
Date Terminated2015-04-29
Product Quantity367 boxes
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.
Firm Action
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.
Root Cause
Incorrect or no expiration date
Distribution Pattern
Worldwide Distribution: US (Nationwide) and country of: Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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