Parker Laboratories Recalls Sterile Ultrasound Gel for Potential Seal Leaks
Parker Laboratories, Inc. is recalling Sterile Aquasonic 100 Ultrasound Transmission Gel because the packet seals may leak.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is FDA Class II involving a sterile medical device with potential seal leaks, which poses a risk of contamination. This falls under 'risk-of-harm products where injury has not yet been reported' as no illnesses or injuries are mentioned in the source.
Plain-English summary
Parker Laboratories, Inc. has initiated a recall of Sterile Aquasonic 100 Ultrasound Transmission Gel, specifically the 20-gram packets (Model Number 01-01-4). The company is recalling 3,275 cases, totaling 1,310,000 packets, due to a potential defect in the packaging.
The recall was prompted by reports that the gel packets may have leaks in the packet seal. This defect could compromise the sterility of the product. The affected products are identified by lot numbers L0117006, L0117007, L0217001, L0217002, L0217004, and L0217006.
The recalled products were distributed to consumers in the United States (specifically California, Florida, Georgia, Iowa, Illinois, Ohio, Tennessee, and Virginia) as well as to Canada, the United Kingdom, and Malta. Consumers who possess these specific lot numbers should stop using the product and contact Parker Laboratories for further instructions.
The recalled product
- Product
- Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
- Manufacturer
- Parker Laboratories, Inc.
- Category
- Medical Device — Ultrasound Gel
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 (6)
- Lot numbers: L0117006
- L0117007
- L0217001
- L0217002
- L0217004
- L0217006
Distribution
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