Parker Eclipse Probe Covers Recalled for Incorrect Expiration Date Labeling
Parker Laboratories is recalling Eclipse Probe Covers due to incorrect expiration dates on inner boxes and plastic bags.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is due to a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Parker Laboratories, Inc. is recalling 367 boxes of Parker Eclipse Probe Covers, Latex Free, REF 38-01. The recall involves Lot #D424 with an expiration date of 04/2016. These products are pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel and are used as protective covers for medical ultrasound probes and transducers.
The recall was initiated after Parker Laboratories received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the affected probe covers. The agency has classified this as a Class II recall.
The affected products were distributed nationwide in the United States and in Canada. Consumers and healthcare facilities should check their inventory for Lot #D424 and contact the manufacturer for instructions on how to return or dispose of the product.
The recalled product
- 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…
- Manufacturer
- Parker Laboratories, Inc.
- Hazard
- Affected units
- 367
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #D424
- Part Number PM-038-0224E and BA-046-3801D 4/27/10
Distribution
Distributed nationwide across the United States.
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