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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2982-2024

Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYND300010P; 4) Flexible LMA Pack with Syringe and Lube, Size 1.5, Pack Number DYND300015P; 5) Flexible LMA Pack with Syringe and Lube, Size 2, Pack Number DYND300020P; 6) Flexible LMA Pack with Syringe and Lube, Size 2.5, Pack Number DYND300025P; 7) Flexible LMA Pack with Syringe and Lube, Size 3, Pack Number DYND300030P; 8) Flexible LMA Pack with Syringe and Lube, Size 4, Pack Number DYND300040P; 9) Flexible LMA Pack with Syringe and Lube, Size 5, Pack Number DYND300050P; 10) TRACHEOSTOMY TRAY , Pack Number DYNDJ1061A ; 11) TRACHEOSTOMY , Pack Number DYNJ45495F

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
CDS983142B , Lot Number 19DBQ261 ; CDS983142B , Lot Number 19FBD886 ; CDS983142B , Lot Number 19KBJ083 ; CDS984376B , Lot Number 21HBJ875 ; CDS984376B , Lot Number 21JBJ731 ; CDS984376B , Lot Number 22DBM097 ; CDS984376B , Lot Number 22EBK349 ; CDS984376B , Lot Number 19EBI656 ; CDS984376B , Lot Number 22HBS594 ; CDS984376B , Lot Number 19SBG293 ; CDS984376B , Lot Number 19IBF800 ; CDS984376B , Lot Number 22LBA281 ; CDS984376B , Lot Number 23ABC499 ; CDS984376B , Lot Number 23ABE884 ; CDS984376B , Lot Number 19VBG331 ; CDS984376B , Lot Number 23BBS463 ; CDS984376B , Lot Number 20DBF949 ; CDS984376B , Lot Number 20EBU288 ; CDS984376B , Lot Number 20HBP449 ; CDS984376B , Lot Number 20IBM472 ; CDS984376B , Lot Number 21ABF587 ; DYND300010P, Lot Number 59220061157; DYND300010P, Lot Number 59220122559; DYND300010P, Lot Number 59221040752; DYND300010P, Lot Number 59221071480; DYND300010P, Lot Number 59222030363; DYND300010P, Lot Number 59222051032; DYND300010P, Lot Number 59222061222; DYND300010P, Lot Number 59222040781; DYND300010P, Lot Number 59222040997; DYND300010P, Lot Number 59222071481; DYND300010P, Lot Number 59222071537; DYND300015P, Lot Number 59220061157; DYND300015P, Lot Number 59220122559; DYND300015P, Lot Number 59221040651; DYND300015P, Lot Number 59221050988; DYND300015P, Lot Number 59221091941; DYND300015P, Lot Number 59222051078; DYND300015P, Lot Number 59222051032; DYND300015P, Lot Number 59222081778; DYND300015P, Lot Number 59222081923; DYND300020P, Lot Number 59220061157; DYND300020P, Lot Number 59221030489; DYND300020P, Lot Number 59221061255; DYND300020P, Lot Number 59221102224; DYND300020P, Lot Number 59221112515; DYND300020P, Lot Number 59221122696; DYND300020P, Lot Number 59222040997; DYND300020P, Lot Number 59222051032; DYND300020P, Lot Number 59222061222; DYND300020P, Lot Number 59222071643; DYND300020P, Lot Number 59222081908; DYND300020P, Lot Number 59222040781; DYND300020P, Lot Number 59222071481; DYND300020P, Lot Number 59222081778; DYND300020P, Lot Number 59222081923; DYND300025P, Lot Number 59220061157; DYND300025P, Lot Number 59221030489; DYND300025P, Lot Number 59221061255; DYND300025P, Lot Number 59221071480; DYND300025P, Lot Number 59222051032; DYND300025P, Lot Number 59222061222; DYND300025P, Lot Number 59222081908; DYND300025P, Lot Number 59222081778; DYND300025P, Lot Number 59222081923; DYND300030P, Lot Number 59220061157; DYND300030P, Lot Number 59221020196; DYND300030P, Lot Number 59221030489; DYND300030P, Lot Number 59221040752; DYND300030P, Lot Number 59221081720; DYND300030P, Lot Number 59222010094; DYND300030P, Lot Number 59222010145; DYND300030P, Lot Number 59222030363; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222040997; DYND300030P, Lot Number 59222051032; DYND300030P, Lot Number 59222061222; DYND300030P, Lot Number 59222071481; DYND300030P, Lot Number 59222071690; DYND300030P, Lot Number 59222081778; DYND300030P, Lot Number 59222081923; DYND300040P, Lot Number 59220061157; DYND300040P, Lot Number 59220122896; DYND300040P, Lot Number 59221030489; DYND300040P, Lot Number 59221050956; DYND300040P, Lot Number 59221061255; DYND300040P, Lot Number 59221061366; DYND300040P, Lot Number 59221071370; DYND300040P, Lot Number 59221071480; DYND300040P, Lot Number 59221071620; DYND300040P, Lot Number 59221050960; DYND300040P, Lot Number 59221061193; DYND300040P, Lot Number 59221081720; DYND300040P, Lot Number 59221102224; DYND300040P, Lot Number 59221112515; DYND300040P, Lot Number 59221112403; DYND300040P, Lot Number 59221122696; DYND300040P, Lot Number 59222030363; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222051032; DYND300040P, Lot Number 59222061222; DYND300040P, Lot Number 59222040781; DYND300040P, Lot Number 59222040923; DYND300040P, L
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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