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Hobbs Medical, Inc. Recall 90769

Description: Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541

Hobbs Medical, Inc. Recall 90769 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0066-2023
Event ID90769
Event DescriptionFreeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
Quantity1 unit
Recall ReasonDevice label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Device Classification20221019
Device Code InfoUDI-DI: M84965840 Lot Numbers: H07-16-033R Kit Lot Number: H09-18-008
Center Classification Date20221007
Recall Initiation Date20220729
Recalling FirmHobbs Medical, Inc.
Initial Notification Letter
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