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MEDLINE INDUSTRIES, LP – Northfield Recall 92486

Description: MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A

MEDLINE INDUSTRIES, LP – Northfield Recall 92486 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2133-2023
Event ID92486
Event DescriptionMEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the country of Panama.
Quantity144 units
Recall ReasonAffected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Device Classification20230719
Device Code InfoUDI/DI (EA) 10159327251772, UDI/DI (CS) 40195327251773; Lot Numbers: 23DDA761
Center Classification Date20230712
Recall Initiation Date20230518
Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Initial Notification N/A
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