Recall Z-2480-2021— AMTEC SALES Inc
Class I · Ongoing
Class I FDA medical device recall by AMTEC SALES Inc, initiated 2021-08-12. It names 3 FDA 510(k) clearances: K962840, K961757, K955246. Product: EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.. Reason: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination..
- Recalling firm
- AMTEC SALES Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2021-08-12
- Firm location
- Miami, FL, United States
510(k) clearances named in this recall
3 on FDA's record- K962840 — ECOLOTION TRANSMISSION AND MASSAGE LOTION
- K961757 — ECOGEL 100 ULTRASOUND GEL
- K955246 — ECOGEL 200 ULTRASOUND GEL
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
EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.
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.