Z-1928-2018 Class I Ongoing
FDA device recall Z-1928-2018 was initiated by Maquet Datascope Corp - Cardiac Assist Division on May 3, 2018 and is designated Class I. Reason for recall: Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy. The recall status is ongoing. Affected quantity: 4300.
Recall Details
- Product Type
- Devices
- Report Date
- June 6, 2018
- Initiation Date
- May 3, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4300
Product Description
Reason for Recall
Distribution Pattern
The devices were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Guam. The devices were distributed to the following foreign countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Brunei, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrica, Taiwan, Thailand, Turkey, UAE, UK, Vietnam, Yemen.