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MEDLINE INDUSTRIES, LP – Northfield Recall 96373

Description: Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS

MEDLINE INDUSTRIES, LP – Northfield Recall 96373 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1463-2025
Event ID96373
Event DescriptionMedline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Quantity1152 units
Recall ReasonMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Device Classification20250402
Device Code Info1) Pack Number DYNJ60655D: UDI/DI 10195327464783 (each), 40195327464784 (case), Lot Number 24AMC692A
Center Classification Date20250326
Recall Initiation Date20250211
Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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