Eco-Med Pharmaceuticals doesn’t know how some of its ultrasound gels got contaminated with the Burkholderia cepacia bacterial complex, but the Canadian company acknowledged the consequences can be serious in recalling eight lots of EcoGel 200 and MediChoice M500812.
Burkholderia cepacia complex “bloodstream infections may result in sepsis and in certain cases, potentially death,” the Eco-Med-written, FDA-posted recall notice stated.
“Use of ultrasound gels manufactured by Eco-Med have been associated with at least 15 infections to date, including bloodstream infections,” the alert admitted. “Additional infections have been identified that may also be associated with the use of this ultrasound gel and investigation is ongoing.”
The recalled EcoGel 200 and MediChoice M500812 lot Nos. are B029; B030; B031; B032; B040; B041; B048; and B055. Patients who’ve undergone ultrasounds recently or who are about to undergo an ultrasound should ask their medical professional what gel was used or will be used.
Also, Eco-Med wants health care facilities around the world to quarantine all lots of these ultrasound gels.
The United States
MediChoice Ultrasound Gel by Owens & Minor and Mac Medical Supply Co Inc.; Chattanooga Conductor USA by DJO Global; DJO Conductor by DJO Global; Liquasonic by Athena Medical Products Inc.; Medline by Medline Industries Inc.; NDC Eco-Gel 200 Ultrasound Gel by NDC Inc.; Omni by Accelerated Care Plus Leasing Inc.
EcoGel 200 by Eco-Med; Active Crystal Inc.; Cardinal Health Canada; CMCC Supply Centre and Bookstore; Christie Innomed Inc.; Dectro International; Medline Canada; Dunbar Medical; Eastern Medical Supply Ltd.; Henry Schein Arcona; Maranda Lauzon Inc.; Strathroy Middlesex General Hospital; Trimedic Supply Network Ltd.; Vitality Depot; Strathroy Middlesex General Hospital; Trimedic Supply Network Ltd.; Ortho Canada; STAT Healthcare Corporation and The Stevens Company Limited.
EcoGel 200 Blue by MJM Distributing; STAT Healthcare Corporation and The Stevens Company Limited.
Medico by Medico Inc.
Red Medical Ultrasound Gel Blue by Red Medical Supplies Ltd.
Conductor Australia by DJO Australia.
EcoGel 200 by Agencia Matamoros.
EcoGel 200 by Good-link Electronics Ltd.
EcoGel 200 by So medico SDN BHD.
EcoGel 200 by Global Medical Solution (NZ) LTD.
EcoGel 200 by Medi’s Part Ltd. and Smart 200 by Smart Technology and Product Co., Ltd.
Medical facilities with any of these gels should fill out Eco-Med’s recall form.
If this gel causes a medical issue with you, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.