FDAFDA · Alimentos y medicamentos·N.º oficial Z-2255-2026
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704.
Publicado el 10 de junio de 2026 · Inicio del retiro: 27 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
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Becton Dickinson & Company
- Distribuidor
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.
- Lote
- 1. Catalog Number: 400866. UDI Number: (01)10885403469497(17)270101(10)B01V232D. Lot Number (Expiration Date): B01V232D (2027-01-01). 2. Catalog Number: 405672. UDI Number: (01)00382904056728(17)270101(10)B03V267D. Lot Number (Expiration Date): B03V267D (2027-01-01). 3. Catalog Number: 405673. UDI Numbers: (01)00382904056735(17)261001(10)B01V225D, (01)00382904056735(17)270101(10)B01V281D, (01)00382904056735(17)261001(10)B02V211D, (01)00382904056735(17)261001(10)B02V217D. Lot Numbers (Expiration Date): B01V225D (2026-10-01), B01V281D (2027-01-01), B02V211D (2026-10-01), B02V217D (2026-10-01). 4. Catalog Number: 405674. UDI Number: (01)00382904056742(17)261001(10)B01V218D. Lot Number (Expiration Date): B01V218D (2026-10-01). 5. Catalog Number: 405675. UDI Numbers: (01)00382904056759(17)261001(10)B01V183D, (01)00382904056759(17)260901(10)B01V198D. Lot Numbers (Expiration Date): B01V183D (2026-10-01), B01V198D (2026-09-01). 6. Catalog Number: 405709. UDI Numbers: (01)00382904057091(17)261001(10)B02V202D, (01)00382904057091(17)260628(10)B02V174D. Lot Numbers (Expiration Date): B02V202D (2026-10-01), B02V174D (2026-06-28). 7. Catalog Number: 405721. UDI Number: (01)00382904057213(17)270101(10)B02V227D. Lot Number (Expiration Date): B02V227D (2027-01-01). 8. Catalog Number: 405723. UDI Number: (01)00382904057237(17)260628(10)B01V174D, (01)00382904057237(17)270101(10)B02V254D, (01)00382904057237(17)261001(10)B01V189D. Lot Numbers (Expiration Date): B01V174D (2026-06-28), B02V254D (2027-01-01), B01V189D (2026-10-01). 9. Catalog Number: 406704. UDI Number: (01)00382904067045(17)270101(10)B02V246D. Lot Number (Expiration Date): B02V246D (2027-01-01).
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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