FDAFDA · Alimentos y medicamentos·N.º oficial Z-2024-2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B; 3. ENT PK 1008847, Medline Kit Number/SKU DYNJ42319C; 4. ENDO SINUS PACK, Medline Kit Number/SKU DYNJ66449; 5. ENT, Medline Kit Number/SKU DYNJ900282I; 6. SEPTO/ENDO, Medline Kit Number/SKU DYNJ902831D; 7. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ906630.
Publicado el 6 de mayo de 2026 · Inicio del retiro: 19 de marzo 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 higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
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.
- Lote
- Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 23DBM600; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 22JBM081; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 22ABJ346; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21KBO873; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21KBO877; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21JBX107; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21BBE213; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21BBB024; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 22AMD386; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21LMC822; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21JMF409; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21IMC184; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21GMB555; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21EMD626; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21CMC668; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21AMB081; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 23FMD067; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 23EMB306; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 23CMD967; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22KMB384; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22OBB494; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22BBT747; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22ABA711; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21LBG900; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21KBD492; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21EBS624; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21CBY739; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21ABL492; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 22KBD211; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 22JBX995; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 22JBL500; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 24CBB115; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 22ABB463; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 22ABB461; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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