FDA Device Recall Z-0010-2022: DJO, LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0010-2022.

Recall Res Number

Z-0010-2022

Recalling Firm / Manufacturer

DJO, LLC

FEI Number

3017264244

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2021-09-07

Date Posted

N/A

Date Terminated

N/A

Product Code

ITX

Event Number

88623

Product Quantity

8,702

Product Description Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:

Reason for Recall Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

Action Details On 09/03/21, recall notices were mailed and emailed to customers. Customers were asked to take the following action: a) Immediately remove and destroy the gel products located in the DJO, LLC / DJO FRANCE kits that contain the affected product. Follow all local/state or country regulations for disposal b) Immediately stop use of ALL ultrasound gels and lotions labeled manufactured by Eco-Med Pharmaceutical (regardless of lot). c) In addition, if you have further distributed this product, please identify your customers, and notify them at once of this product recall by sharing this recall notification letter. d) DJO, LLC / DJO FRANCE has partnered with Stericycle/Sedgwick as our vigilance partner. Please complete the attached Return Response and return to DJOglobalrecall@sedgwick.com. The following website is provided: djoglobal.com

Distribution Pattern Worldwide distribution - U.S. Nationwide distribution including in the states of ND, NJ, CO, HI, CA, MA, FL, GA, IN, WA, NY, TX, IA, TN, NV, LA, CT, VA, NC, WI, MS, OR, MI, AL, MN, VT, IL, OH, AR, NM, DE, PA, SC, AZ, MD, RI, KY, UT, MO, OK, MT, ID, NE, WY, ME, WV, SD, KS, PR, NH, DC, AK, VI and the countries of France, China, Mexico, Ontario, Australia.

Code Information / Serial Numbers All Lots manufactured by Eco-Med Pharmaceutical, Inc

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DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. Registration: 9616086 View Registration
INNOLATEX SDN. BHD Registration: 9616515 View Registration
RIMED LTD Registration: 9616774 View Registration
Wipro GE Healthcare Private Ltd. Registration: 9617277 View Registration
BARD REYNOSA S.A. DE C.V. Registration: 9617592 View Registration
KAREX INDUSTRIES SDN BHD Registration: 9680135 View Registration
BK MEDICAL APS Registration: 9680269 View Registration
QUANTEL MEDICAL Registration: 9680671 View Registration
Arrow Internacional de Chihuahua S.A. de C.V. Registration: 9680794 View Registration
MING FAI INDUSTRIAL (SHENZHEN) CO. LTD. Registration: 9710018 View Registration
GE ULTRASOUND KOREA, LTD. Registration: 9710090 View Registration
NATIONAL THERAPY PRODUCTS INC. Registration: 9710388 View Registration
GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 View Registration

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0010-2022

Recall Parameters & Description

Related Establishments / Registrations

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