The Recall Desk
SevereFDA (Devices)·Z-0224-2022·Announced 2021-11-24

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
  • bacterial-contamination

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.