Z-1049-2019 Class II Terminated
FDA device recall Z-1049-2019 was initiated by LW Scientific, Inc. on February 6, 2019 and is designated Class II. Reason for recall: The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surround… The recall status is terminated (terminated May 7, 2021). Affected quantity: 226 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- February 6, 2019
- Termination Date
- May 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 226 units
Product Description
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in test tubes (15ml)
Reason for Recall
The clear, plastic, polycarbonate hematocrit rotor may break apart during use and be ejected through the plastic housing, posing a safety hazard to the technician and potentially damaging the surrounding area.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Philippines, Honduras, El Salvador, Australia, Guatemala, Canada, Singapore, Australia, Peru, Nicaragua, Trinidad and Tobago, and New Zealand
Code Information
Serial Numbers: 6C1712002, 6C1712008, 6C1803021, 6C1803022, 6C1803053, 6C1803053, 6C1803054, 6C1803055, 6C1803057, 6C1803058, 6C1803059, 6C1803060, 6C1803097, 6C1803124, 6C1803128, 6C1803129, 6C1803134, 6C1803135, 6C1803136, 6C1803140, 6C1805146, 6C1805147, 6C1805148, 6C1805149, 6C1805150, 6C1805151, 6C1805152, 6C1805153, 6C1805154, 6C1805155, 6C1805156, 6C1805157, 6C1805158, 6C1805159, 6C1805160, 6C1805161, 6C1805162, 6C1805163, 6C1805164, 6C1805165, 6C1805166, 6C1805167, 6C1805168, 6C1805169, 6C1805170, 6C1805171, 6C1805172, 6C1805173, 6C1805174, 6C1805175, 6C1805176, 6C1805177, 6C1805177, 6C1805178, 6C1805179, 6C1805180, 6C1805181, 6C1805182, 6C1805183, 6C1805184, 6C1805185, 6C1805186, 6C1805187, 6C1805188, 6C1805189, 6C1805190, 6C1805191, 6C1805192, 6C1805193, 6C1805194, 6C1805195, 6C1805196, 6C1805197, 6C1805198, 6C1805199, 6C1805200, 6C1805201, 6C1805202, 6C1805203, 6C1805204, 6C1805205, 6C1805206, 6C1805207, 6C1805208, 6C1805209, 6C1805209, 6C1805210, 6C1805211, 6C1805212, 6C1805213, 6C1805214, 6C1805218, 6C1805219, 6C1805220, 6C1805221, 6C1805222, 6C1805223, 6C1805224, 6C1805225, 6C1805226, 6C1805227, 6C1805228, 6C1805229, 6C1805230, 6C1805231, 6C1805232, 6C1805233, 6C1805234, 6C1805235, 6C1805236, 6C1805237, 6C1805238, 6C1805239, 6C1805240, 6C1805241, 6C1805242, 6C1805243, 6C1805244, 6C1805245, 6C1810346, 6C1810347, 6C1810348, 6C1810349, 6C1810350, 6C1810351, 6C1810352, 6C1810353, 6C1810354, 6C1810355, 6C1810356, 6C1810357, 6C1810358, 6C1810359, 6C1810360, 6C1810361, 6C1810362, 6C1810363, 6C1810364, 6C1810365, 6C1810366, 6C1810370, 6C1810371, 6C1810372, 6C1810373, 6C1810374, 6C1810375, 6C1810376, 6C1810378, 6C1810379, 6C1810380, 6C1810381, 6C1810386, 6C1810387, 6C1810388, 6C1810389, 6C1810390, 6C1810391, 6C1810392, 6C1810393, 6C1810394, 6C1810395, 6C1810396, 6C1810397, 6C1810398, 6C1810399, 6C1810400, 6C1810401, 6C1810404, 6C1810405, 6C1810406, 6C1810407, 6C1810408, 6C1810409, 6C1810410, 6C1810411, 6C1810412, 6C1810413, 6C1810414, 6C1810415, 6C1810416, 6C1810417, 6C1810418, 6C1810419, 6C1810420, 6C1810421, 6C1810422, 6C1810423, 6C1810424, 6C1810425, 6C1810426, 6C1810427, 6C1810428, 6C1810429, 6C1810434, 6C1810435, 6C1810436, 6C1810437, 6C1810438, 6C1810439, 6C1810440, 6C1811448, 6C1811449, 6C1811450, 6C1811451, 6C1811452, 6C1811453, 6C1811454, 6C1811455, 6C1811464, 6C1811465, 6C1811466, 6C1811467, 6C1811504, 6C1811505, 6C1811506, 6C1811507, 6C1811508, 6C1811509, 6C1811510, 6C1811511, 6C1811540, 6C1811541, 6C1811542, 6C1811543, 6C183137, 6C183138