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Medline brand medical procedure convenience kits, labeled as recallZ-0160-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Sep 4, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0160-2025
Status
Open, Classified
Initiated by the company
Sep 4, 2024
Posted by the FDA
Oct 23, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
2740 units
Product code
OGR
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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

Devices named in this recall

32 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 95415).

Sources and updates

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