FDAFDA · Alimentos y medicamentos·N.º oficial Z-1293-2014
Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.
Publicado el 2 de abril de 2014 · Inicio del retiro: 11 de marzo de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Teleflex Medical
- Distribuidor
- Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
- Lote
- Product Code: 833-123, Lot numbers: 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, & 02K1102309; Product Code: 833-124, Lot numbers: 02A1200503, 02B1101450 & 02C0903400; Product Code: 02D0900010, 02D0900103, 02D1003285, 02D1003286 & 02F1302321; Product Code: 02G1000045, 02G1300348, 02G1301122, 02H1100494, & 02L0803407; Product Code: 02L1100009, 02M1002289, 02M1101933 & 02F1302322; 833-213, Lot number: 02H1100687; Product Code: D-5007K, Lot numbers: 02B1002310, 02C1103731, 02F1100069 & 02H1102294; Product Code: D-5007M4A, Lot number: 02M0902844; Product Code: D-5007M4K, Lot numbers: 02C1002252, & 02F1100124; Product Code: D-7016M4K, Lot number: 02G1301749; Product Code: D-7070K, Lot numbers: 02A1103450 & 02B1002276: Product Code: D-7070M4K, Lot numbers: 02C1103707, 02F1301100, 02G1100876 & 02G1301739; Product Code: D-7076M1K, Lot number: 02H1103237; Product Code: D-7076M4K, Lot numbers: 02F1101036, 02J1301343, and 02K0900010: Product Code: D-7375K, Lot number: 02A1201015; Product Code: D-793M4K, Lot number: 02L1002488; Product Code: ED-6072, Lot numbers: 02C1002218, 02E1002342 & 02J0902517; Product Code: ED-6276, Lot number: 02F0902457; Product Code: ED-6896, Lot numbers: 02A0902278, 02B0900089, 02B0901762, 02C0900661, 02C1002207, 02D0900634, 02D1100186, 02E0901921, 02E0902608, 02E1301581, 02H1300608, 02J0900501, 02K0901590, 02K0902406, 02L0900676, 02M0901869, & 02G1301755; Product Code: ED-853, Lot numbers: 02G1002594, 02B0902976, 02D0902457 & 02M0901348 and Product Code: EP4049N, Lot number: 02A1003137.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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