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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2232-2026

Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit SKU DYNJRA1555; 2) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1817; 3) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA1920; 4) ULTRASOUND GUIDED NERVE BLOCK, Medline Kit SKU DYNJRA2013; 5) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2017; 6) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067; 7) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067A; 8) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2093; 9) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2117A; 10) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124; 11) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124A; 12) PAIN TRAY, Medline Kit SKU DYNJRA2144; 13) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2221; 14) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2333; 15) SPINAL TRAY, Medline Kit SKU DYNJRA2390; 16) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2402; 17) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407; 18) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407A; 19) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407B; 20) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447; 21) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447A; 22) SPINAL TRAY 25G, Medline Kit SKU DYNJRA2488A; 23) J&S SPINAL TRAY, Medline Kit SKU DYNJRA2545; 24) SPINAL TRAY, Medline Kit SKU DYNJRA2549; 25) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2550; 26) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2552; 27) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554; 28) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554A; 29) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2578; 30) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2588; 31) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2602; 32) SPINAL TRAY, Medline Kit SKU DYNJRA2618; 33) SPINAL TRAY, Medline Kit SKU DYNJRA2619; 34) SPINAL TRAY, Medline Kit SKU DYNJRA2622; 35) SPINAL BLOCK 25 WHITACRE 5S ND, Medline Kit SKU DYNJRA2624; 36) SPINAL TRAY, Medline Kit SKU DYNJRA2631; 37) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2632; 38) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2633; 39) SPINAL TRAY, Medline Kit SKU DYNJRA2645; 40) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2654; 41) CSE PAIN MANAGEMENT TRAY, Medline Kit SKU DYNJRA2665; 42) SPINAL TRAY, Medline Kit SKU DYNJRA2667; 43) SPINAL TRAY 24G BD, Medline Kit SKU DYNJRA2675; 44) SPINAL TRAY W/ CHLORAPREP, Medline Kit SKU DYNJRA2680; 45) SPINAL TRAY, Medline Kit SKU DYNJRA2682; 46) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2684; 47) SPINAL TRAY, Medline Kit SKU DYNJRA2725; 48) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2757; 49) TRAY, 25G SPINAL W/RX DURAPREP, Medline Kit SKU DYNJRA9039; 50) TRAY, 25G SPINAL W/RX, Medline Kit SKU DYNJRA9045; 51) SLSYSTEM CSE TRAY, Medline Kit SKU PAIN2333; 52) 25G SPINAL BLOCK TRAY, Medline Kit SKU SAMPA0135.

Publicado el 3 de junio de 2026 · Inicio del retiro: 10 de abril de 2026

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.

Qué hacer

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Detalles del retiro

Fabricante
Medline Industries, LP
Distribuidor
Worldwide - US Nationwide distribution in the US Territory of Virgin Islands and the countries of Bahamas, Panama, Barbados.
Lote
Medline SKU DYNJRA1555: UDI/DI 10193489238723 each, 40193489238724 case, Lot Numbers: 25CLA724; Medline SKU DYNJRA1555: UDI/DI 10193489238723 each, 40193489238724 case, Lot Numbers: 25CLA306; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMH667; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMC856; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25JMA370; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25IMI402; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25HME985; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 25AMI063; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 24JMI488; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 24JMA113; Medline SKU DYNJRA1817: UDI/DI 10193489942354 each, 40193489942355 case, Lot Numbers: 23KMD776; Medline SKU DYNJRA1920: UDI/DI 10195327111168 each, 40195327111169 case, Lot Numbers: 25FBQ144; Medline SKU DYNJRA2013: UDI/DI 10195327212049 each, 40195327212040 case, Lot Numbers: 26ABV382; Medline SKU DYNJRA2013: UDI/DI 10195327212049 each, 40195327212040 case, Lot Numbers: 24GBA206; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 26BMJ305; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25LMA710; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25JMI170; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25JMA642; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25GMH968; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25EMJ739; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25DMF107; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 25DMB676; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 24HMD119; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 24DMB563; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 23IBL595; Medline SKU DYNJRA2017: UDI/DI 10195327217402 each, 40195327217403 case, Lot Numbers: 23GBO103; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 25EMJ740; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 25EMB776; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 25DMH562; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 25DMD631; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24JMA116; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24FMI984; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24EMC757; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24CMH743; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 24BBP785; Medline SKU DYNJRA2067: UDI/DI 10195327269142 each, 40195327269143 case, Lot Numbers: 23HBQ128; Medline SKU DYNJRA2067A: UDI/DI 10198459371967 each, 40198459371968 case, Lot Numbers: 26BBJ400; Medline SKU DYNJRA2093: UDI/DI 10195327296797 each, 40195327296798 case, Lot Numbers: 23JBQ988; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 26BMC993; Medline SKU DYNJRA2117A: UDI/DI 10198459009273 each, 40198459009274 case, Lot Numbers: 26AMF175
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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