FDAFDA · Alimentos y medicamentos·N.º oficial Z-2503-2026
MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the recall documents for a full list of affected products)
Publicado el 24 de junio de 2026 · Inicio del retiro: 4 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
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
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 distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
- Lote
- Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24GMJ742; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24FMC978; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24CMA556; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24BMI027; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24AMF247; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 24AMA807; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23IMF051; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23HMG141; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23EMF259; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23DMA689; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23CMF097; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 23CMC699; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22LME333; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22KMB390; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22HMC449; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22GMD678; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22FMG214; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22DME100; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22CME928; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22BMG698; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 22AMD289; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21KMD167; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21JMF926; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21IMD987; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21GME755; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21FBF900; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21CBF873; Medline Kit Number/SKU DYNJ905924B: UDI/DI 10193489773484 (each), 40193489773485 (case), Lot Number 21ABE015; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 26DME629; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25LMG110; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25LMB085; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25IMH993; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25EMC711; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25DMH514; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 40198459256401 (case), Lot Number 25CMD890; Medline Kit Number/SKU DYNJ905924D: UDI/DI 10198459256400 (each), 4019845925640
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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