Z-1193-2019 Class I Terminated
FDA device recall Z-1193-2019 was initiated by Edwards Lifesciences, LLC on March 21, 2019 and is designated Class I. Reason for recall: Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets. The recall status is terminated (terminated November 28, 2023). Affected quantity: 22443.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- March 21, 2019
- Termination Date
- November 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22443
Product Description
Reason for Recall
Distribution Pattern
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