FDAFDA · Alimentos y medicamentos·N.º oficial Z-0328-2025
BioZorb Marker. Radiographic soft tissue marker.
Publicado el 4 de diciembre de 2024 · Inicio del retiro: 10 de octubre 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
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Hologic, Inc
- Distribuidor
- Domestic: US Nationwide Distribution.
- Lote
- Model No. F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, F0202; UDI-DI: 15420045514065, 15420045514058, 15420045514041, 15420045514034, 15420045514027, 15420045514010, 15420045514003, 15420045513990, 15420045513983; Lot No. 22E24RH, 23A09RK, 23L23RP, 22E24RG, 23A09RJ, 23E03R, 23G28RW, 22F06RL, 22G26RQ, 22K25RA, 23A09RH, 23A30RP, 23C02RJ, 23H25RW, 23K04RC, 23K31RG, 24A30RG, 22D21RBB, 22F06RK, 22F29RK, 22G26RP, 22H24RM, 22J26RG, 22K25R, 22L22R, 22M20RM, 23A26RV, 23C02RH, 23E27RF, 23F29RT, 23H03R, 23H25RU, 23K04RA, 23L23RK, 24B02RD, 24B27RK, 22D21RAA, 22E24RA, 22F29RJ, 22G26RN, 22H24RL, 22J26RF, 22K21R, 22L22RA, 22M20RL, 23A26RU, 23C02RG, 23C30RQ, 23E03RA, 23F29RP, 23G28RV, 23H25RV, 23K02RB, 23K31RD, 23L23RH, 24A08RY, 24B01R, 24B27RL, 24C22RN, 22D21RZ, 22E24RB, 22F25RF, 22G26RM, 22H24RK, 22J26RD, 22K19RW, 22L22RB, 23C02RK, 23E25RY, 23F29RS, 23H24RP, 23K04RB, 23K31RF, 23L23RJ, 22D21RY, 22E24R, 22F25RD, 22G26RL, 22H22RT, 22J26RC, 22K19RV, 22L22RC, 23A09RN, 23H03RA, 23H31R, 23K04RD, 23K25RM, 22D21RX, 22E20RAA, 22F21R, 22G21RM, 22H22RS, 22J22RBB, 22K19RU, 22L22RF, 23A09RM, 23A30RQ, 23B24RZ, 23C30RP, 23D27RJ, 23E31RD, 23F28RZ, 23G31RJ, 23H24RQ, 23K02RA, 23K25RN, 22D20RV, 22E20RZ, 22F16RV, 22G21RL, 22H20R, 22J22RAA, 22K19RT, 22K25RB, 22L22RD, 23A09RL, 23B24RY, 23C28RJ, 23D27RH, 23E30RF, 23F29RQ, 23G31RH, 23H24RN, 23K02R, 23K25RL.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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