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FDA (Device enforcement)Recalled 2024-10-16class ii

MEDLINE INDUSTRIES, LP - Northfield: MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRA

Hazard

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Details from the source

Reason for recall: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. Distribution: US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands Lot/code info: Codes: 1) DYNJRA1268B, UDI/DI 10193489370485 (each) 40193489370486 (case), Lot Numbers: 20FLA512, 20HLA422, 20ILA296, 20ILA327, 20LLA223, 21ALA087, 21CLA525; 2) DYNJRA1268C, UDI/DI 10193489905830 (each) 40193489905831 (case), Lot Numbers: 21ELA224, 21ELA333, 21GLA292, 21GLA895, 21HLA924, 21ILA773, 21JLA824, 22ALA237, 22BLA899, 22DLA197, 22DLA409, 22ELA583, 22ELB120, 22FLA820, 22FLB163, 22GLB081, 22HLA566, 22ILA092, 22LLA800, 23DLA368, 23FLA942, 23GLA321, 23HLA910, 23ILA593, 23JLA268; 3) DYNJRA1739A, UDI/DI 1019348992495 (each) 40193489924955 (case), Lot Numbers: 23CBE392; 4) DYNJRA1739B, UDI/DI 10195327411237 (each) 40195327411238 (case), Lot Numbers: 23FBL394, 23GBV201, 23HBG282, 23HBG968, 23IBQ191; 5) DYNJRA1869, UDI/DI 10195327018818 (each) 40195327018819 (case), Lot Numbers: 23CBE391; 6) DYNJRA9035, UDI/DI 10884389618448 (each) 40884389618449 (case), Lot Numbers: 22GBO435, 22IBI073, 23BBB167, 23BBS677, 23CBL304, 23FBI382; 7) DYNJRA9040, UDI/DI 10193489830514 (each) 40193489830515 (case), Lot Numbers: 23CBO446, 23DBK742, 23HBG091, 23HBG092; 8) EPIREINF19O, UDI/DI 10195327222970 (each) 40195327222971 (case), Lot Numbers: 22HBB281, 23EBO266, 23GBA230, 23HBN806, 23HBR131, 23HBY420; 9) EPIREINF29C, UDI/DI 10195327114367 (each) 40195327114368 (case), Lot Numbers: 22FBU886, 22HBD608, 22KBK655, 22NBE738, 23ABH589, 23DBK772, 23DBN448, 23JBU253; 10) PAIN0384B, UDI/DI 10193489926842 (each) 40193489926843 (case), Lot Numbers: 23BMC466, 23FMJ516, 23FMJ523, 23FMJ721, 23HMA617, 23LMB080

UPC codes

10193489370485, 40193489370486, 10193489905830, 40193489905831, 1019348992495, 40193489924955, 10195327411237, 40195327411238, 10195327018818, 40195327018819, 10884389618448, 40884389618449, 10193489830514, 40193489830515, 10195327222970, 40195327222971, 10195327114367, 40195327114368, 10193489926842, 40193489926843, 1019532736489, 40195327364893, 10193489619201, 40193489619202, 10195327288211, 40195327288212, 10888277797109, 40888277797100, 10193489336726, 40193489336727, 10193489586749, 40193489586740, 10193489586848, 40193489586849, 1019532713519, 40195327135196, 1019532731038, 40195327310388, 10193489288582, 40193489288583

Source

Official record: FDA (Device enforcement)

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

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