Medical Device
Manufacturing
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Z-1048-2019Class II

LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C

LW Scientific, Inc. / initiated 2019-02-06 / Terminated / root cause: design

LW Scientific, Inc. began a recall of LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1048-2019
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
LW Scientific, Inc.
Product
LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes
Product code
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
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.
Root cause tag
design
FDA root cause
Device Design
Action
The recall was initiated by telephone on 02/06/2019. Initial requesting that the consignee immediately cease use of the product. Recall notices were disseminated by telephone and email requesting the return of the product beginning 02/13/2019. The recall is to the user level. The firm has posted a notice on their website stating there is a voluntary recall due to a safety issue and asking users to call if they have a unit purchased after 9/28/18.
Quantity in commerce
142 units
Distribution
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
Product codes and lots
Serial Numbers: 24H1712209, 24H1712302, 24H1712305, 24H1712306, 24H1712308, 24H1712313, 24H1712314, 24H1712315, 24H1712316, 24H1712319-1, 24H1804183, 24H1804184, 24H1804185, 24H1804186, 24H1804187, 24H1804188, 24H1804189, 24H1804190, 24H1804191, 24H1804192, 24H1804193, 24H1804194, 24H1804195, 24H1804196, 24H1804197, 24H1804198, 24H1804199, 24H1804200, 24H1804201, 24H1804202, 24H1804207, 24H1804208, 24H1804209, 24H1804210, 24H1804211, 24H1804212, 24H1804213, 24H1804214, 24H1804215, 24H1804216, 24H1804217, 24H1804218, 24H1804219, 24H1804220, 24H1804221, 24H1804222, 24H1804223, 24H1804224, 24H1804225, 24H1804226, 24H1804227, 24H1804228, 24H1804229, 24H1804230, 24H1804231, 24H1804232, 24H1804233, 24H1804234, 24H1804235, 24H1804236, 24H1804237, 24H1804238, 24H1804239, 24H1804240, 24H1804241, 24H1804242, 24H1804243, 24H1804244, 24H1804245, 24H1804246, 24H1804247, 24H1804248, 24H1804249, 24H1804250, 24H1804251, 24H1804252, 24H1804253, 24H1804254, 24H1804255, 24H1804256, 24H1804257, 24H1804258, 24H1804259, 24H1804260, 24H1804261, 24H1804262, 24H1804263, 24H1804264, 24H1804265, 24H1804266, 24H1804267, 24H1804268, 24H1804269, 24H1804270, 24H1804271, 24H1804272, 24H1804273, 24H1804274, 24H1804278, 24H1804279, 24H1804280, 24H1804281, 24H1804282, 24H1810336, 24H1810337, 24H1810338, 24H1810339, 24H1810340, 24H1810341, 24H1810342, 24H1810343, 24H1810352, 24H1810353, 24H1810355, 24H1810360, 24H1810361, 24H1810362, 24H1810363, 24H1810367, 24H1810368, 24H1810369, 24H1810370, 24H1810371, 24H1810373, 24H1810386, 24H1810387, 24H1810393, 24H1810394, 24H1810395, 24H1810405, 24H1810410, 24H1810412, 24H1810413, 24H1810414, 24H1810415, 24H1810416, 24H1810417, 24H1810418, 24H1810419, 24H1810424, 24H1810425, 24H1810428

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1048-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1048-2019Class IITerminatedVoluntary: Firm initiated
Z-1049-2019Class IITerminatedVoluntary: Firm initiated
Z-1050-2019Class IITerminatedVoluntary: Firm initiated