Product Safety Recalls

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Abbott Recall 89123

Description: Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM

Abbott Recall 89123 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0420-2022
Event ID89123
Event DescriptionUltimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
Quantity10 units
Recall ReasonAs a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
Device Classification20220105
Device Code InfoModel 407831, Lot 7748246, GTIN: 15414734008805
Center Classification Date20211227
Recall Initiation Date20211116
Recalling FirmAbbott
Initial Notification Telephone
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