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MEDLINE INDUSTRIES, LP – Northfield Recall 91387

Description: Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case

MEDLINE INDUSTRIES, LP – Northfield Recall 91387 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1032-2023
Event ID91387
Event DescriptionNon-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
Product TypeDevices
DistributionUS Nationwide distribution in the states of AR, MD, WA, WI.
Quantity160 cases (480 units)
Recall ReasonPotential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Device Classification20230208
Device Code InfoItem Number: DYNJ900416M, UDI/GTIN Case: 40195327031672, UDI/GTIN Each: 10195327031671, Lot Number: 22IBQ980
Center Classification Date20230127
Recall Initiation Date20221117
Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Initial Notification Letter
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