Z-0101-2014 Class II Terminated
FDA device recall Z-0101-2014 was initiated by HemoCue AB on July 25, 2013 and is designated Class II. Reason for recall: HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches. The recall status is terminated (terminated August 11, 2014). Affected quantity: 42,330 packages/4 boxes/25 microcuvetes.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2013
- Initiation Date
- July 25, 2013
- Termination Date
- August 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42,330 packages/4 boxes/25 microcuvetes
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution which includes the following states: AK, AL, AS, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY,MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, WA, WI, VT, WV & WY and the countries of Armenia, Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, El Salvador Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Israel, Ivory Coast, Netherlands, New Zealand, Norway, Peru, Poland, Russia, South Africa, Sweden, Switzerland and Taiwan.