Recall Z-0224-2022— Scrip Inc

Name: FDA recall Z-0224-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-18

Class I · Ongoing

Class I FDA medical device recall by Scrip Inc, initiated 2021-08-18. It names one FDA 510(k) clearance: K955246. Product: Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue. Reason: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination..

Recalling firm: Scrip Inc
Classification: Class I
Status: Ongoing
Initiated: 2021-08-18
Firm location: Peoria, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K955246 — ECOGEL 200 ULTRASOUND GELEco-Med Pharmaceuticals, Inc.·cleared 1996-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.