FDAFDA · Alimentos y medicamentos·N.º oficial Z-2505-2026
MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,TVH PACK, etc (see 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 DYNJ61063A: UDI/DI 10193489640458 (each), 40193489640459 (case), Lot Number 21KBV571; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 23EBU351; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 23DBQ190; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 23BBE364; Medline Kit Number/SKU DYNJ61063B: UDI/DI 10195327193478 (each), 40195327193479 (case), Lot Number 22IBW094; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 26CMK666; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 26BMG709; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 26AMI644; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25KMD133; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25JMA568; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25IMF717; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25HMJ595; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25FMH149; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25EME964; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25DMG466; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25CMH227; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25CMC736; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 25BMB744; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24LMB964; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24JMB516; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24JMA159; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24EMI862; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24DMG741; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24CBP782; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24CMI475; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24BBU531; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 24BBB690; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23LBH349; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23JBP275; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23IBU481; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23GBW750; Medline Kit Number/SKU DYNJ61063C: UDI/DI 10195327451684 (each), 40195327451685 (case), Lot Number 23GBB691; Medline Kit Number/SKU DYNJ50874C: UDI/DI 10195327024963 (each), 40195327024964 (case), Lot Number 22ABS574; Medline Kit Number/SKU DYNJ50874C: UDI/DI 10195327024963 (each), 40195327024964 (case), Lot Number 22ABI415; Medline Kit Number/SKU DYNJ50874C: UDI/DI 10195327024963 (each), 40195327024964 (case), Lot Number 21KBN568; Medline Kit Number/SKU DYNJ50874D: UDI/DI 10195327165383 (each), 40195327165384 (case), Lot Number 24CBV299; Medl
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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