—#210182

Product

Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40836F; 7) ENT PACK, REF DYNJ44249J; 8) TONSIL PACK, REF DYNJ44349L; 9) TONSIL PACK, REF DYNJ44349M; 10) NASAL PACK, REF DYNJ53200C; 11) TONSIL & ADENOIDS PACK, REF DYNJ53270C; 12) FTMC MYRINGOTOMY PACK-LF, REF DYNJ54610A; 13) HEAD AND NECK PACK, REF DYNJ55255C; 14) ENT T&A PACK, REF DYNJ58979; 15) EENT PACK, REF DYNJ62927; 16) ENT, REF DYNJ63190A; 17) D L B PACK, REF DYNJ66274A; 18) ASC T&A, REF DYNJ67109B; 19) TONSIL T AND A PACK SHD, REF DYNJ68417C; 20) T A PACK, REF DYNJ80227B; 21) TONSIL AND ADENOID PACK, REF DYNJ80559A; 22) T AND A PACK UMMC KIT, REF DYNJ81880; 23) T/A ENDO PACK, REF DYNJ83158; 24) JVL - MODULE T A PK, REF DYNJ84083; 25) T&A, REF DYNJ900289J; 26) T&A, REF DYNJ900289J; 27) T & A, REF DYNJ902626G; 28) LARYNGOSCOPY BRONCH-LF, REF DYNJ903264A; 29) T&A, REF DYNJ903428J; 30) T&A, REF DYNJ903428J; 31) PEDI ENT - OAKBEND, REF DYNJ905769; 32) T & A, REF DYNJ907056C; 33) ASC FARRELL T&A, REF DYNJ908132; 34) CHS ENT PACK, REF DYNJCH500

FDA product code: OGR — Ear, Nose, And Throat Surgical Tray
Device class: Class 1
Medical specialty: Ear, Nose, Throat
Affected lot / code info: 1) REF CDS982091I, UDI/DI 40193489741644 (each), 10193489741643 (case), Lot Numbers: 24BBA623; 2) REF CDS984492B, UDI/DI 40193489637183 (each), 10193489637182 (case), Lot Numbers: 24ABB114; 3) REF DYNJ0798129I, UDI/DI 40195327226511 (each), 10195327226510 (case), Lot Numbers: 23KBB859; 4) REF DYNJ30591I, UDI/DI 40193489962841 (each), 10193489962840 (case), Lot Numbers: 24ABD228; 5) REF DYNJ37171A, UDI/DI 40884389750620 (each), 10884389750629 (case), Lot Numbers: 23KBD998; 6) REF DYNJ40836F, UDI/DI 40195327059539 (each), 10195327059538 (case), Lot Numbers: 23LBQ627; 7) REF DYNJ44249J, UDI/DI 40195327483020 (each), 10195327483029 (case), Lot Numbers: 23KBE536; 8) REF DYNJ44349L, UDI/DI 40195327394531 (each), 10195327394530 (case), Lot Numbers: 23KBD353; 9) REF DYNJ44349M, UDI/DI 40195327564378 (each), 10195327564377 (case), Lot Numbers: 24ABA446; 10) REF DYNJ53200C, UDI/DI 40193489779371 (each), 10193489779370 (case), Lot Numbers: 23KBC298; 11) REF DYNJ53270C, UDI/DI 40193489812566 (each), 10193489812565 (case), Lot Numbers: 23KBA462; 12) REF DYNJ54610A, UDI/DI 40195327456451 (each), 10195327456450 (case), Lot Numbers: 24ABD026; 13) REF DYNJ55255C, UDI/DI 40195327493753 (each), 10195327493752 (case), Lot Numbers: 23KBD956; 14) REF DYNJ58979, UDI/DI 40889942914938 (each), 10889942914937 (case), Lot Numbers: 24ABD861; 15) REF DYNJ62927, UDI/DI 40193489700245 (each), 10193489700244 (case), Lot Numbers: 23LBQ806; 16) REF DYNJ63190A, UDI/DI 40193489304603 (each), 10193489304602 (case), Lot Numbers: 23LBN122; 17) REF DYNJ66274A, UDI/DI 40195327151981 (each), 10195327151980 (case), Lot Numbers: 24ABB272; 18) REF DYNJ67109B, UDI/DI 40195327207084 (each), 10195327207083 (case), Lot Numbers: 24ABC426; 19) REF DYNJ68417C, UDI/DI 40195327341634 (each), 10195327341633 (case), Lot Numbers: 23KBC605; 20) REF DYNJ80227B, UDI/DI 40195327220144 (each), 10195327220143 (case), Lot Numbers: 24ABC423; 21) REF DYNJ80559A, UDI/DI 40195327512522 (each), 10195327512521 (case), Lot Numbers: 23LBP334; 22) REF DYNJ81880, UDI/DI 40195327153671 (each), 10195327153670 (case), Lot Numbers: 24ABE284; 23) REF DYNJ83158, UDI/DI 40195327236886 (each), 10195327236885 (case), Lot Numbers: 23LBU511; 24) REF DYNJ84083, UDI/DI 40195327332236 (each), 10195327332235 (case), Lot Numbers: 23LBL823; 25) REF DYNJ900289J, UDI/DI 40195327554034 (each), 10195327554033 (case), Lot Numbers: 24ABS131; 26) REF DYNJ900289J, UDI/DI 40195327554034 (each), 10195327554033 (case), Lot Numbers: 24ABE249; 27) REF DYNJ902626G, UDI/DI 40195327214334 (each), 10195327214333 (case), Lot Numbers: 24ABU280; 28) REF DYNJ903264A, UDI/DI 40889942632566 (each), 10889942632565 (case), Lot Numbers: 23LBF682; 29) REF DYNJ903428J, UDI/DI 40195327575060 (each), 10195327575069 (case), Lot Numbers: 24CBI692; 30) REF DYNJ903428J, UDI/DI 40195327575060 (each), 10195327575069 (case), Lot Numbers: 24ABS337; 31) REF DYNJ905769, UDI/DI 40193489507998 (each), 10193489507997 (case), Lot Numbers: 24ABS137; 32) REF DYNJ907056C, UDI/DI 40195327276875 (each), 10195327276874 (case), Lot Numbers: 24ABA207; 33) REF DYNJ908132, UDI/DI 40193489981521 (each), 10193489981520 (case), Lot Numbers: 24CBA800; 34) REF DYNJCH500, UDI/DI 40884389900421 (each), 10884389900420 (case), Lot Numbers: 23LBP611

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 #210182. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.