Product Safety Recalls

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Abbott Recall 90106

Description: FIRMap" Catheter, 60mm Basket

Abbott Recall 90106 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1213-2022
Event ID90106
Event DescriptionFIRMap" Catheter, 60mm Basket
Product TypeDevices
DistributionUS Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
Quantity40 units
Recall ReasonIncorrect product labeling.
Device Classification20220608
Device Code InfoModel Number: AR064060; UDI Number: ( 01) 0 0810591 02002 4 ( 17) 020531 ( 00) 1 2345678 95; Batch Numbers: 2158303 (Exp. Date: 30 NOV 2022), 2159876 (Exp. Date: 31 JAN 2023), 2156510 (Exp. Date: 30 SEP 2022), 2162996 (Exp. Date: 31 MAR 2023), 2159875 (Exp. Date: 30 NOV 2022), and 2159877 ( Exp. Date: 30 NOV 2022).
Center Classification Date20220601
Recall Initiation Date20220428
Recalling FirmAbbott
Initial Notification Letter
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