Recall Z-0068-2022— National Distribution & Contracting Inc

Name: FDA recall Z-0068-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-24

Class I · Ongoing

Class I FDA medical device recall by National Distribution & Contracting Inc, initiated 2021-08-24. It names one FDA 510(k) clearance: K962681. Product: ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl. Reason: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination..

Recalling firm: National Distribution & Contracting Inc
Classification: Class I
Status: Ongoing
Initiated: 2021-08-24
Firm location: La Vergne, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K962681 — ECOGEL 300 TENS GELEco-Med Pharmaceuticals, Inc.·cleared 1996-10-04

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

ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl

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.