Product Safety Recalls

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XVIVO PERFUSION AB Recall 90143

Description: XVIVO Organ Chamber REF 19020

XVIVO PERFUSION AB Recall 90143 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1212-2022
Event ID90143
Event DescriptionXVIVO Organ Chamber REF 19020
Product TypeDevices
DistributionU.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland
Quantity80 devices
Recall ReasonThe weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Device Classification20220608
Device Code InfoModel Number: 19020 Lot Numbers/UDI Codes: LOT: 13801, UDI: (01)07350069520074(17)240930(10)13801 LOT: 13802, UDI: (01)07350069520074(17)240930(10)13802 LOT: 13803, UDI: (01)07350069520074(17)240930(10)13803 LOT: 13804, UDI: (01)07350069520074(17)240930(10)13804 LOT: 13805, UDI: (01)07350069520074(17)240930(10)13805 LOT: 13806, UDI: (01)07350069520074(17)240930(10)13806
Center Classification Date20220601
Recall Initiation Date20220408
Recalling FirmXVIVO PERFUSION AB
Initial Notification Letter
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