CLASS II Device recall · Reported 5 Nov 2014 · FDA Enforcement Report
Parker Eclipse Probe Cover, Latex Free recalled by Parker Laboratories
Parker Laboratories is recalling Parker Eclipse Probe Cover, Latex Free, distributed nationwide in the US. The recall was initiated on 6 Aug 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0145-2015
- FDA event ID
- 69224
- Recalling firm
- Parker Laboratories, Fairfield, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2014
- FDA classified
- 28 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Foreign Material
- Device type
- Imaging Equipment
Timeline
| 6 Aug 2014 | Recall initiated by company | |
| 28 Oct 2014 | Classified by FDA | +83 days |
| 5 Nov 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (Nationwide) and country of: Canada.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #D424, Part Number PM-038-0224E and BA-046-3801D 4/27/10
Where was it sold?
Worldwide Distribution: US (Nationwide) and country of: Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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