Product Safety Recalls

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Velano Vascular Recall 89185

Description: PIVO Blood Collection Device 20G, REF: 202-0005

Velano Vascular Recall 89185 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0527-2022
Event ID89185
Event DescriptionPIVO Blood Collection Device 20G, REF: 202-0005
Product TypeDevices
DistributionUS Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ, MI, FL, NC.
Recall ReasonIncomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no clinical effect up to bloodstream infection.
Device Classification20220202
Device Code InfoUDI: 00850984007027. Lots: 070621-02, 062221-01, 061021-02, 052721-03, 051421-02
Center Classification Date20220125
Recall Initiation Date20211110
Recalling FirmVelano Vascular
Initial Notification Letter
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