Z-1079-2013 Class II Terminated
FDA device recall Z-1079-2013 was initiated by Thermo Fisher Scientific (Asheville) LLC on November 29, 2012 and is designated Class II. Reason for recall: Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field. The recall status is terminated (terminated April 14, 2015). Affected quantity: 15,567 incubators.
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2013
- Initiation Date
- November 29, 2012
- Termination Date
- April 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,567 incubators
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the states of: 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, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SN, TN, TX, UT, VA, VT, WA, WI, WV & WY. and the countries: AFGHANISTAN, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, COSTA RICA, DENMARK, EGYPT, ENGLAND, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KOREA, LEBANON, MALAYSIA, MEXICO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PEOPLES REPUBLIC OF CHINA, PERU, PHILIPPINES, PORTUGAL, QATAR, REPUBLIC OF PANAMA, ROMANIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VENEZUELA, VIETNAM & WEST INDIES.