EV1000 Clinical Platform recall
EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of…
Why was EV1000 Clinical Platform recalled?
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots
- Product
- EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of…
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 22443
- Distribution
- Worldwide Distribution - US Nationwide : FL, MD, NY, TX, VA, CO, OK, MO, CA, DE, TN, NC, DC, PA, MA, OR, SC, OH, WI, KS, NV, MI, IL, KY, GA, NJ, WA, CT, IN, MN, WV, LA, MS, AL, SD, NE, IA, AZ, ID, HI, UT, ME,MT, NM, AK, NH, RI, AR, ND, WY, PR. Foreign (OUS): IT, FI, CO, KR, JP, PL, BE, GR, NL, IL, AT, DK,CA, GB, BR, SA, SE, DE, AU, FR, MX, IN, IC, ZA, ES, TR, NZ, MY, IE, SG, CZ, SI, PT, CH, RE, LK, CR, AR, HK, NO, PY, PA, MT, EG, NP, TN, RU, RO, NA,CL, BH, IR, PH, TH, KZ, DZ, BG, EE, KW, VN, OM, PE, EC, AE, MA, VE, BO, QA, DO, GT, BY, JO, LT, SK, HU, CY, MN, TW, CN
- Recall date
- May 29, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)