—#210201

Product

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

FDA product code: OJH — Orthopedic Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Timeline

Recall initiated: 2024-09-04
Posted by FDA: 2024-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210201. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.