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FDA (Device enforcement)Recalled 2024-03-22class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYN

Hazard

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Details from the source

Reason for recall: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. Distribution: Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore. Quantity: 6998 units Lot/code info: a) REF DYNJ909932, UDI/DI 40195327511167 (case), 10195327511166 (unit), Lot Numbers: 23JBI290, 23KBI103; b) REF DYKE1007B, UDI/DI 40195327203697 (case), 10195327203696 (unit), Lot Numbers: 22HBF709, 22HBV977, 22LBC080, 22LBH793, 23CBP363, 23DBL601, 23EBT148, 23FBS311, 23GBP583, 23HBY932, 23JBK265,; c) REF DYNJ909935, UDI/DI 40195327511198 (case), 10195327511197 (unit), Lot Numbers: 23JBH869; d) REF DYNJ902624G, UDI/DI 40195327214525 (case), 10195327214524 (unit), Lot Numbers: 22IBA877, 22IBN753, 23DBG397, 23FBN458, 23GBG939, 23HBT691, 23JBQ259, 23KBO185; e) REF DYNJ902377I, UDI/DI 40195327505883 (case), 10195327505882 (unit), Lot Numbers: 23JBI663; f) REF DYNJ65475B, UDI/DI 40195327303519 (case), 10195327303518 (unit), Lot Numbers: 22LBE939, 23ABK037, 23BBI110, 23CBH860, 23DBF474, 23DBS953, 23GBN857, 23JBE718, 23KBL576; g) REF DYNJ65487B, UDI/DI 40195327303663 (case), 10195327303662 (unit), Lot Numbers: 22LBP408, 23ABN443, 23CBM523, 23DBM713, 23IBM894; h) REF DYNJ906898, UDI/DI 40193489281928 (case), 10193489281927 (unit), Lot Numbers: 22HBA414, 22JBR764, 23FBK308, 23GBC593, 23IBF940, 23KBO165, 23KBT057; i) REF DYNJ906897B, UDI/DI 40195327373147 (case), 10195327373146 (unit), Lot Numbers: 23EBE963, 23EBL760, 23FBC942, 23FBC943, 23HBQ553, 23HBS215, 23IBD903, 23KBE192, 23KBI100, 23LBH012; j) REF DYNJ906914, UDI/DI 40193489280174 (case), 10193489280173 (unit), Lot Numbers: 22EBS455, 22EBU139, 22GBK146, 22HBG371, 22JBG419, 22KBI283, 23ABC387, 23CBI473, 23CBO589, 23CBU019, 23EBE95

UPC codes

40195327511167, 10195327511166, 40195327203697, 10195327203696, 40195327511198, 10195327511197, 40195327214525, 10195327214524, 40195327505883, 10195327505882, 40195327303519, 10195327303518, 40195327303663, 10195327303662, 40193489281928, 10193489281927, 40195327373147, 10195327373146, 40193489280174, 10193489280173, 40195327511006, 10195327511005

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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