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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1367-2026

Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060

Publicado el 25 de febrero de 2026 · Inicio del retiro: 12 de diciembre de 2025

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

Due to damage to outer tray that can potentially compromise the sterile barrier

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Bard Peripheral Vascular Inc
Distribuidor
Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, Vietnam.
Lote
Product Name: Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600060 UDI code: (01)00801741051692(17)300728(10)HUKV0547 Lot Number: HUKV0547 Product Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600100 UDI code: (01)00801741051708(17)300628(10)HUKU0307 (01)00801741051708(17)300828(10)HUKW1312 Lot Number: HUKU0307 HUKW1312 Product Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray (Short External Length) with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600120 UDI code: (01)00801741051715(17)300628(10)HUKU0274 Lot Number: HUKU0274 Product Name: Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600310 UDI code: (01)00801741051739(17)300428(10)HUKS0783 (01)00801741051739(17)300628(10)HUKU0250 (01)00801741051739(17)300628(10)HUKU0310 Lot Number: HUKS0783 HUKU0250 HUKU0310 Product Name: Hickman 12 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600350 UDI code: (01)00801741051777(17)300428(10)HUKR1359 (01)00801741051777(17)300428(10)HUKS0811 (01)00801741051777(17)300628(10)HUKU0316 Lot Number: HUKR1359 HUKS0811 HUKU0316 Product Name:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600520 UDI code: (01)00801741051807(17)270528(10)HUKS1468 (01)00801741051807(17)270528(10)HUKU0246 (01)00801741051807(17)270528(10)HUKU0278 (01)00801741051807(17)270528(10)HUKU0289 (01)00801741051807(17)270528(10)HUKU0305 (01)00801741051807(17)270528(10)HUKU0327 (01)00801741051807(17)270528(10)HUKU0338 (01)00801741051807(17)270528(10)HUKU0353 (01)00801741051807(17)270528(10)HUKW0164 (01)00801741051807(17)280328(10)HUKW1278 (01)00801741051807(17)280328(10)HUKW1285 Lot Number: HUKS1468 HUKU0246 HUKU0278 HUKU0289 HUKU0305 HUKU0327 HUKU0338 HUKU0353 HUKW0164 HUKW1278 HUKW1285 Product Name:Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600540 UDI code: (01)00801741051821(17)290428(10)HUKR0064 (01)00801741051821(17)290628(10)HUKR0065 (01)00801741051821(17)290628(10)HUKR0067 (01)00801741051821(17)300128(10)HUKU0252 (01)00801741051821(17)300128(10)HUKU0270 (01)00801741051821(17)300128(10)HUKU0279 (01)00801741051821(17)300128(10)HUKU0308 (01)00801741051821(17)300128(10)HUKU0334 (01)00801741051821(17)300328(10)HUKV0359 (01)00801741051821(17)300328(10)HUKV0550 (01)00801741051821(17)300328(10)HUKV0560 (01)00801741051821(17)300328(10)HUKW0156 (01)00801741051821(17)300328(10)HUKW0159 Lot Number: HUKR0064 HUKR0065 HUKR0067 HUKU0252 HUKU0270 HUKU0279 HUKU0308 HUKU0334 HUKV0359 HUKV0550 HUKV0560 HUKW0156 HUKW0159 Product Name:Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600560 UDI code: (01)00801741051845(17)290828(10)HUKS0776 (01)00801741051845(17)290828(10)HUKS0816 (01)00801741051845(17)290928(10)HUKS1220 (01)00801741051845(17)290928(10)HUKU0302 (01)00801741051845(17)290928(10)HUKU0311 (01)00801741051845(17)300128(10)HUKU0345 (01)00801741051845(17)300128(10)HUKU0350 (01)00801741051845(17)300128(10)HUKV0376 (01)00801741051845(17)300128(10)HUKV0555 Lot Number: HUKS0776 HUKS0816 HUKS1220 HUKU0302 HUKU0311 HUKU0345 HUKU0350 HUKV0376 HUKV0555 Product Name:Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600570 UDI code: (01)00801741051869(17)290628(10)HUKR1342 (01)00801741051869(17)290628(10)HUKR1344 (01)00801741051869(17)300128(10)HUKR1346 (01)00801741051869(17)290628(10)HUKR1347 (01)00801741051869(17)300128(10)HUKR1348 (01)00801741051869(17)300128(10)HUKR1356 (01)00801741051869(17)290628(10)HUKR1363 (01)00801741051869(17)290628(10)HUKR1367 (01)00801741051869(17)300128(10)HUKR1368 (01)00801741051869(17)300
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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