FDA Recalls Scrip Ultrasound Gel for Potential Bacterial Contamination
Scrip Inc is recalling Scrip Ultrasound Gel Clear (5L) nationwide due to potential bacterial contamination. Affected units may cause harm if contaminated product contacts patients during ultrasound procedures.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation requires a minimum severity score of 4 per classification rules. Bacterial contamination in a medical device that directly contacts patients presents direct risk of harm warranting immediate corrective action.
Plain-English summary
Scrip Inc is recalling Scrip Ultrasound Gel Clear, 5L (Item Number 663 0061), a medical device intended for use in acoustic coupling of ultrasound transducers to tissue. Approximately 1001 gallons of the product have been distributed nationwide to all 50 states.
The product, which bears an older logo indicating manufacture by Eco-Med Pharmaceuticals in Canada, may contain bacterial contamination that could potentially harm patients if the contaminated product contacts them during ultrasound procedures.
Patients and healthcare facilities that have received this product should stop using it immediately. Anyone who has used the product should contact their healthcare provider if they experience signs of infection or other health concerns.
The recalled product
- Product
- Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
- Manufacturer
- Scrip Inc
- Category
- Medical Device
- Hazard
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 (1)
- Item Number: 663 0061
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Scrip Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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