FDAFDA · Alimentos y medicamentos·N.º oficial Z-2453-2026
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OPEN HEART ADULT, Model Number: CDS840396AA; 4) CABG A CDS, Model Number: CDS982269N; 5) OPEN HEART ANESTHESIA PACK, Model Number: CDS983849G; 6) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 7) OPEN HEART A, Model Number: CDS985105Q; 8) OPEN HEART PART 2, Model Number: DYNJ901075R; 9) VPH OPEN HEART, Model Number: DYNJ902664L; 10) HEART A, Model Number: DYNJ903465I; 11) HEART, Model Number: DYNJ903822F; 12) OPEN HEART BASIC B, Model Number: DYNJ904311F; 13) SM OPEN HEART PACK A&B, Model Number: DYNJ904749J; 14) OPEN HEART ANESTHESIA ICC-B, Model Number: DYNJ905567B; 15) SILVER CROSS OPEN HEART, Model Number: DYNJ906102K; 16) ANESTHESIA OPEN HEART, Model Number: DYNJ906225I; 17) OPEN HEART COMBO, Model Number: DYNJ907400F; 18) CARDIAC CABG B, Model Number: DYNJ908121C; 19) FS OPEN HEART, Model Number: DYNJ908308A; 20) OPEN HEART SUPPLEMENT, Model Number: DYNJ909116D; 21) MEM CARDIAC, Model Number: DYNJ9622573AP; 22) OPEN HEART A & B PACK, Model Number: DYNJ9718008AT
Publicado el 1 de julio de 2026 · Inicio del retiro: 6 de mayo 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
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medline Industries, LP
- Distribuidor
- US Nationwide.
- Lote
- 1) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24LBH805; 2) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24HBM100; 3) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25ABR195; 4) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25EBS810; 5) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25FBS936; 6) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25GBX096; 7) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 25IBT859; 8) CDS840144Q, UDI-DI: 10195327263102(each), 40195327263103(case), Lot Number: 24KBE879; 9) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26DBF234; 10) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26ABG176; 11) CDS840144R, UDI-DI: 10198459561627(each), 40198459561628(case), Lot Number: 26ABK484; 12) CDS840150W, UDI-DI: 10195327648046(each), 40195327648047(case), Lot Number: 24HBQ201; 13) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 25CBD369; 14) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 25DBL498; 15) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBD200; 16) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBD223; 17) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24LBR405; 18) CDS840150X, UDI-DI: 10198459112386(each), 40198459112387(case), Lot Number: 24JBX455; 19) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25FBD604; 20) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25FBT739; 21) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25HBT720; 22) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25JBE191; 23) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 25JBW220; 24) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 26ABP964; 25) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 26BBD028; 26) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 26BBF355; 27) CDS840150Y, UDI-DI: 10198459303029(each), 40198459303020(case), Lot Number: 26CBB249; 28) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25FBD477; 29) CDS840396AA, UDI-DI: 10198459348686(each), 40198459348687(case), Lot Number: 25HBM750; 30) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25IBD204; 31) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25JBQ605; 32) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 25KBK109; 33) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 26ABD873; 34) CDS840396AB, UDI-DI: 10198459468742(each), 40198459468743(case), Lot Number: 26ABT718; 35) CDS840396AC, UDI-DI: 10198459639494(each), 40198459639495(case), Lot Number: 26DLA888; 36) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBG163; 37) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25BBP788; 38) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBD493; 39) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 25CBK781; 40) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24KBK977; 41) CDS840396Y, UDI-DI: 10195327574932(each), 40195327574933(case), Lot Number: 24IBK539; 42) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 25BBB644; 43) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 25BBR673; 44) CDS980952AN, UDI-DI: 10198459022531(each), 40198459022532(case), Lot Number: 24LBM011; 45) CDS980952AN, UDI-DI: 1019845902253
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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