Z-0145-2015Class 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...

Name: Z-0145-2015 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...
Creator: Parker Laboratories, Inc.
Published: 2014-08-06
License: https://open.fda.gov/license/

Parker Laboratories, Inc. / initiated 2014-08-06 / Terminated

FDA source

Parker Laboratories, Inc. began a recall of 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... on 2014-08-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0145-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-06
Posted: 2014-10-29
Terminated: 2015-04-29
Recalling firm: Parker Laboratories, Inc.
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.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
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.
FDA root cause: Incorrect or no expiration date
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.
Quantity in commerce: 367 boxes
Distribution: Worldwide Distribution: US (Nationwide) and country of: Canada.
Product codes and lots: Lot #D424, Part Number PM-038-0224E and BA-046-3801D 4/27/10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0145-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0145-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-28

Product code IYO

K953673Class IIEclipse Probe CoverParker Laboratories, Inc. / cleared 1996-03-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)