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U.S. Department of Health and Human Services

Class 1 Device Recall Gel Conductor

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  Class 1 Device Recall Gel Conductor see related information
Date Initiated by Firm September 07, 2021
Create Date October 05, 2021
Recall Status1 Open3, Classified
Recall Number Z-0009-2022
Recall Event ID 88623
510(K)Number K955246  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description:
2073/ INTELECT RPW 120V,
2073-BR/ INTELECT RPW 120V BRAZIL,
2074/ INTELECT RPW 230 V,
2082/ INTELECT RPW 100 V,
2760/ INTELECT LEGEND XT COMBOUS STD,
2791/ INTELECT LEGEND XT COMBO US STD W/CART,
2782-10/ INTELECT TRANSPORT US STD,
2782-2/ INTELECT TRANSPORT US STD,
2843/ INTELECT VET 4CH COMBO PKG,
2845K/ KIT INTELECT VET 4CH COMBO PKG,
2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM,
2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL,
2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL,
2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD,
2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL,
2792/ VECTRA GENISYS 2CH COMBO US STD W/CART,
2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL,
2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL,
2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL,
2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL,
2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL,
2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL,
2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART,
2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL,
2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL,
2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL,
2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL,
2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL,
2796/ VECTRA GENISYS 4CH COMBO US STD W/CART,
2796K/ KIT VECTRA GENISYS 4CH COMBO P,
2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL,
2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL,
2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL,
2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL,
2738/ INTELECT TRANSPORT COMBO PKG US STD,
8250KP/ KIT TRITON DTS PROMO,
6001/ INTELECT NEO,
2738-10/ INTELECT TRANSPORT COMBO PKG US STD,
2738-2/ INTELECT TRANSPORT COMBO PKG US STD,
2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD,
2776/ INTELECT MOBILE INT'L STD 5CM APPL,
27800/ ULTRASOUND ON CART,
2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL,
2776-10/ INT MOBIL INT'L STD 10CM APPL,
2776-2/ INT MOBILE INT'L STD 2CM APPL,
2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL,
2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL,
2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL,
2752CC/ INT ADV 2CH COLOR COMBO INT'L STD,
2756/ INTELECT VET 2CH COMBO PKG INT'L STD,
2844K/ KIT INTELECT VET 2CH COMBO PKG,
2782/ INTELECT TRANSPORT US STD,
2895K/ KIT CART ADAPT BL W/CT/SPEC US,
2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD,
2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART,
2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD,
2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART,
7550/ INT LEGEND COMBO 4C US STD,
INT001/ INTELECT LEGEND ULTRASOUND US STD,
INTC B/ INT CB PKGD US STD,
39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO,
39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO,
13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES,
15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG,
15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS,
15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG,
15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS,
2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG,
2174KIT/ INTELECT RPW 2 230V KIT EU PLUG,
2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG,
2176KIT/ INTELECT RPW 2 120V USA KIT,
12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD,
2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD,
70002/ NEO MODULE ULTRASOUND
Code Information All Lots Manufactured by Eco-Med Pharmaceutical, Inc
Recalling Firm/
Manufacturer		 DJO, LLC
5919 Sea Otter Pl Ste 200
Carlsbad CA 92010-6750
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action 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
Quantity in Commerce 67,485
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = ITX and Original Applicant = ECO-MED PHARMACEUTICALS, INC.
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