Product Safety Recalls

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Abbott Recall 89714

Description: Amplatzer Steerable Delivery Sheath

Abbott Recall 89714 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0895-2022
Event ID89714
Event DescriptionAmplatzer Steerable Delivery Sheath
Product TypeDevices
DistributionOUS distribution only
Quantity529 units
Recall ReasonInstructions for use were updated.
Device Classification20220413
Device Code InfoModel ASDS-14F-075, Batch Numbers: 1) 7963817 2) 7976534 3) 7981029 4) 7990340 5) 8008111 6) 8010056 7) 8025120 8) 8102214 9) 8106240 10) 8234848 11) 8274323 12) 8277741
Center Classification Date20220407
Recall Initiation Date20211109
Recalling FirmAbbott
Initial Notification E-Mail
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