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FDAFDA · Food and drugs·Recall number Z-0179-2025

Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAVIGATIONAL SPINE FUSION, REF DYNJ45153B; 7) FEET, ELBOW, AND ANKLE TEGH-LF, REF DYNJ46719B; 8) PLASTIC HAND PACK TEGH-LF, REF DYNJ46739B; 9) CVL INSERTION KIT-LF, REF DYNJ48587A; 10) CVL INSERTION KIT-LF, REF DYNJ48587A; 11) ENSEMBLE SURPLUS LCA-LF, REF DYNJ48892C; 12) EXTREMITY PACK, REF DYNJ49301B; 13) ACL ACCESSORY PACK, REF DYNJ50952F; 14) SPINAL INJECTION PACK, REF DYNJ51383F; 15) FTMC ARTHROS BASIC SETUP-LF, REF DYNJ54602A; 16) MINOR EXTREMITY PACK, REF DYNJ55324G; 17) MINOR EXTREMITY PACK, REF DYNJ55324G; 18) D-SPINE SUPPLEMENT PACK, REF DYNJ58115A; 19) EXTREMITY PACK, REF DYNJ62877; 20) AHT LG KNEE ROLL, REF DYNJ64823; 21) CUSTOM ORTHO PACK, REF DYNJ83675; 22) DR SUNDAR SCS KIT, REF DYNJ85288A; 23) CENTRAL SCS TRIAL PACK, REF DYNJ85503; 24) TOTAL KNEE CDS-LF, REF DYNJ909569; 25) EXTREMITY PACK, REF SYNJ10253B; 26) CARROLLTON HIP FX, REF SYNJ910003A; 27) ARTHROSCOPY, REF SYNJ910004C

Published October 30, 2024 · Recall initiated: September 4, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Distributor
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Lot
1) REF CDS982519W, UDI/DI 40195327389971 (each), 10195327389970 (case), Lot Numbers: 24BBQ775; 2) REF CDS984003A, UDI/DI 40888277002891 (each), 10888277002890 (case), Lot Numbers: 24ABG354; 3) REF DYNJ32639C, UDI/DI 40889942919223 (each), 10889942919222 (case), Lot Numbers: 23KBE944; 4) REF DYNJ39547B, UDI/DI 40193489760485 (each), 10193489760484 (case), Lot Numbers: 23LBO506; 5) REF DYNJ41229C, UDI/DI 40195327609727 (each), 10195327609726 (case), Lot Numbers: 24ABK563; 6) REF DYNJ45153B, UDI/DI 40195327235414 (each), 10195327235413 (case), Lot Numbers: 24ABD667; 7) REF DYNJ46719B, UDI/DI 40889942279303 (each), 10889942279302 (case), Lot Numbers: 23LBP194; 8) REF DYNJ46739B, UDI/DI 40889942314318 (each), 10889942314317 (case), Lot Numbers: 24ABG221; 9) REF DYNJ48587A, UDI/DI 40889942313106 (each), 10889942313105 (case), Lot Numbers: 23LBO732; 10) REF DYNJ48587A, UDI/DI 40889942313106 (each), 10889942313105 (case), Lot Numbers: 23KBO606; 11) REF DYNJ48892C, UDI/DI 40889942791768 (each), 10889942791767 (case), Lot Numbers: 23KBB893; 12) REF DYNJ49301B, UDI/DI 40889942686613 (each), 10889942686612 (case), Lot Numbers: 24ABB592; 13) REF DYNJ50952F, UDI/DI 40193489361668 (each), 10193489361667 (case), Lot Numbers: 23LBV189; 14) REF DYNJ51383F, UDI/DI 40193489225588 (each), 10193489225587 (case), Lot Numbers: 23LBS071; 15) REF DYNJ54602A, UDI/DI 40195327456673 (each), 10195327456672 (case), Lot Numbers: 23LBO084; 16) REF DYNJ55324G, UDI/DI 40195327433964 (each), 10195327433963 (case), Lot Numbers: 23LBL961; 17) REF DYNJ55324G, UDI/DI 40195327433964 (each), 10195327433963 (case), Lot Numbers: 23KBE137; 18) REF DYNJ58115A, UDI/DI 40195327582037 (each), 10195327582036 (case), Lot Numbers: 23LBL852; 19) REF DYNJ62877, UDI/DI 40193489695824 (each), 10193489695823 (case), Lot Numbers: 23LBV377; 20) REF DYNJ64823, UDI/DI 40193489221054 (each), 10193489221053 (case), Lot Numbers: 23LBK801; 21) REF DYNJ83675, UDI/DI 40195327296408 (each), 10195327296407 (case), Lot Numbers: 24ABG702; 22) REF DYNJ85288A, UDI/DI 40195327543083 (each), 10195327543082 (case), Lot Numbers: 24ABG603; 23) REF DYNJ85503, UDI/DI 40195327509904 (each), 10195327509903 (case), Lot Numbers: 23LBS030; 24) REF DYNJ909569, UDI/DI 40195327399703 (each), 10195327399702 (case), Lot Numbers: 24BBF009; 25) REF SYNJ10253B, UDI/DI 40193489373593 (each), 10193489373592 (case), Lot Numbers: 24ABG182; 26) REF SYNJ910003A, UDI/DI 40889942848448 (each), 10889942848447 (case), Lot Numbers: 24ABW931; 27) REF SYNJ910004C, UDI/DI 40195327246748 (each), 10195327246747 (case), Lot Numbers: 24BBC876
Risk classification
Class II
Area (FDA)
device
Country
United States

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