FDAFDA · Alimentos y medicamentos·N.º oficial Z-2507-2026
MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J; 3) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775K; 4) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775L; 5) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775M; 6) TONSIL PACK, Medline Kit Number/SKU DYNJ84480; 7) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080; 8) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080A.
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 CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 24BBF438; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23LBR516; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23LBI385; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23GBW083; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23GBT137; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23GBA705; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23EBT206; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23BBN853; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23BBG437; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23BBG444; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23BBA852; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 23BBA859; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22IBR361; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22IBF066; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22GBA053; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22GBA052; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22GBA054; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22DBM893; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22DBS377; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22OBE639; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22ABB399; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 22ABB400; Medline Kit Number/SKU CDS983775I: UDI/DI 10193489980660 (each), 40193489980661 (case), Lot Number 24ABX491; Medline Kit Number/SKU CDS983775J: UDI/DI 10195327684761 (each), 40195327684762 (case), Lot Number 24GBG807; Medline Kit Number/SKU CDS983775J: UDI/DI 10195327684761 (each), 40195327684762 (case), Lot Number 24FBI951; Medline Kit Number/SKU CDS983775J: UDI/DI 10195327684761 (each), 40195327684762 (case), Lot Number 24EBH007; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 25GMD344; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 25EMG590; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 25EMC381; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 25CMJ064; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 25CMC688; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 25BMC192; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 24KBS115; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 24KBF283; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 24JBD646; Medline Kit Number/SKU CDS983775K: UDI/DI 10198459086991 (each), 40198459086992 (case), Lot Number 24IBK663; Medl
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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