FDAFDA · Alimentos y medicamentos·N.º oficial Z-3029-2024
Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 4) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324A; 5) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNDH1514; 6) BIOPSY KIT, Pack Number DYNDH1570; 7) MYELOGRAM TRAY, Pack Number DYNDH1574; 8) BONE MARROW ASPIRATION AND BIOPSY, Pack Number DYNDH1596; 9) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNDH1638; 10) BIOPSY PACK, Pack Number DYNDH1699; 11) LACERATION TRAY, Pack Number DYNDL1159B; 12) SUTURE TRAY, Pack Number DYNDS1064B; 13) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 14) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 15) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320; 16) ARTHROGRAM PACK, Pack Number P241108; 17) PACK BONE MARROW BIOPSY, Pack Number P268481; 18) BIOPSY BASIC PACK, Pack Number P784604; 19) ARTHROGRAM TRAY-LF, Pack Number SPEC0061B; 20) BIOPSY TRAY, Pack Number SPEC0095; 21) RADIOLOGY/BIOPSY, Pack Number SPEC0149; 22) BONE MARROW TRAY, Pack Number SPEC0255; 23) ARTHROGRAM TRAY-LF, Pack Number SPEC0400
Publicado el 18 de septiembre de 2024 · Inicio del retiro: 8 de abril de 2024
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
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
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 - Northfield
- Distribuidor
- Worldwide distribution.
- Lote
- DM645, Lot Number 2019120980; DYNDC1960A, Lot Number 2022040790; DYNDH1319, Lot Number 2020122250; DYNDH1324A, Lot Number 2020122250; DYNDH1514, Lot Number 2020040250; DYNDH1514, Lot Number 2020050750; DYNDH1570, Lot Number 2022011450; DYNDH1574, Lot Number 2022011450; DYNDH1596, Lot Number 2020122250; DYNDH1596, Lot Number 2022092090; DYNDH1638, Lot Number 2021062150; DYNDH1638, Lot Number 2021092350; DYNDH1638, Lot Number 2022011450; DYNDH1638, Lot Number 2022060750; DYNDH1699, Lot Number 2022060750; DYNDL1159B, Lot Number 2019022580; DYNDS1064B, Lot Number 2019062480; DYNDS1064B, Lot Number 2019120980; DYNJTS0214, Lot Number 2020113050; DYNJTS0214, Lot Number 2021012850; DYNJTS0214, Lot Number 2021050750; DYNJTS0214, Lot Number 2021082650; DYNJTS0214, Lot Number 2021102550; DYNJTS0214, Lot Number 2021111290; DYNJTS0214, Lot Number 2022040790; DYNJTS0214, Lot Number 2022052690; DYNJTS0214, Lot Number 2022080390; DYNJTS0214, Lot Number 2022092090; DYNJTS0214, Lot Number 2022102190; DYNJTS0214, Lot Number 2023100990; DYNJTS0214, Lot Number 2024010890; DYNJTS4306, Lot Number 2022011450; IVS3320, Lot Number 2021111290; P241108, Lot Number 2021012850; P268481, Lot Number 2022060750; P784604, Lot Number 2019120980; SPEC0061B, Lot Number 2021062150; SPEC0095, Lot Number 2020113050; SPEC0095, Lot Number 2022060750; SPEC0149, Lot Number 2020113050; SPEC0255, Lot Number 2019022580; SPEC0255, Lot Number 2019032580; SPEC0255, Lot Number 2019062480; SPEC0255, Lot Number 2019120980; SPEC0255, Lot Number 2019121080; SPEC0255, Lot Number 2020012080; SPEC0400, Lot Number 2020113050
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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