Recall Z-2469-2021— Mac Medical Supply Co Inc

Name: FDA recall Z-2469-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-04

Class I · Ongoing

Class I FDA medical device recall by Mac Medical Supply Co Inc, initiated 2021-08-04. It names one FDA 510(k) clearance: K955246. Product: Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel. Reason: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination..

Recalling firm: Mac Medical Supply Co Inc
Classification: Class I
Status: Ongoing
Initiated: 2021-08-04
Firm location: Munster, IN, 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

Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200 Multi-Purpose CLEAR Ultrasound Gel

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.