FDA Device Recall Z-0224-2022

Scrip Inc · Peoria, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue

Lot / serial / GTIN: Item Number: 663 0061, all lots bearing old style logo. Older logo states that product was manufactured by Eco-Med Pharmaceuticals in Canada.

Quantity: 1001 gallons

Reason for recall

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

Recall record

Recall number: Z-0224-2022
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US Nationwide Distribution to all 50 states.
Recall initiated: 2021-08-18
Classified by FDA Center: 2021-11-17
FDA published: 2021-11-24
Recalling firm: Scrip Inc
Firm location: Peoria, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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