CLASS II ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report
Broviac 4. Single-Lumen CV Catheter Cutdown Tray recalled
Bard Peripheral Vascular is recalling Broviac 4. Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat, distributed nationwide in the US. The recall was initiated on 12 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1367-2026
- FDA event ID
- 98222
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Dec 2025
- FDA classified
- 13 Feb 2026
- Reported
- 25 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 12 Dec 2025 | Recall initiated by company | |
| 13 Feb 2026 | Classified by FDA | +63 days |
| 25 Feb 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to damage to outer tray that can potentially compromise the sterile barrier
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
Due to damage to outer tray that can potentially compromise the sterile barrier
Which lots are affected?
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)300128(10)HUKS0774 (01)00801741051869(17)300128(10)HUKU0238 (01)00801741051869(17)300128(10)HUKU0242 (01)00801741051869(17)300128(10)HUKU0247 (01)00801741051869(17)300128(10)HUKU0253 (01)00801741051869(17)300128(10)HUKU0254 (01)00801741051869(17)300128(10)HUKU0266 (01)00801741051869(17)300128(10)HUKU0280 (01)00801741051869(17)300128(10)HUKU0283 (01)00801741051869(17)300128(10)HUKU0284 (01)00801741051869(17)300128(10)HUKU0290 (01)00801741051869(17)300128(10)HUKU0293 (01)00801741051869(17)300128(10)HUKU0294 (01)00801741051869(17)300128(10)HUKU0298 (01)00801741051869(17)300128(10)HUKU0312 (01)00801741051869(17)300128(10)HUKU0339 (01)00801741051869(17)300328(10)HUKU0340 (01)00801741051869(17)300128(10)HUKU0344 (01)00801741051869(17)300128(10)HUKU0354 (01)00801741051869(17)300328(10)HUKV0549 (01)00801741051869(17)300328(10)HUKV0569 (01)00801741051869(17)300328(10)HUKV0576 (01)00801741051869(17)300328(10)HUKV0581 (01)00801741051869(17)300328(10)HUKW0148 Lot Number: HUKR1342 HUKR1344 HUKR1346 HUKR1347 HUKR1348 HUKR1356 HUKR1363 HUKR1367 HUKR1368 HUKS0774 HUKU0238 HUKU0242 HUKU0247 HUKU0253 HUKU0254 HUKU0266 HUKU0280 HUKU0283 HUKU0284 HUKU0290 HUKU0293 HUKU0294 HUKU0298 HUKU0312 HUKU0339 HUKU0340 HUKU0344 HUKU0354 HUKV0549 HUKV0569 HUKV0576 HUKV0581 HUKW0148 Product Name:Hickman 12 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600620 UDI code: (01)00801741051913(17)291028(10)HUJY0302 (01)00801741051913(17)291028(10)HUJY1095 (01)00801741051913(17)291128(10)HUJZ1332 (01)00801741051913(17)291128(10)HUJZ1336 (01)00801741051913(17)291128(10)HUJZ1339 (01)00801741051913(17)291128(10)HUJZ1340 (01)00801741051913(17)300328(10)HUKR1349 (01)00801741051913(17)300328(10)HUKR1364 (01)00801741051913(17)300428(10)HUKS0784 (01)00801741051913(17)300428(10)HUKS0806 (01)00801741051913(17)300428(10)HUKS1217 (01)00801741051913(17)230428(10)HUKS1218 (01)00801741051913(17)300628(10)HUKU0259 (01)00801741051913(17)300628(10)HUKU0351 (01)00801741051913(17)300728(10)HUKV0349 (01)00801741051913(17)300728(10)HUKV0567 (01)00801741051913(17)300828(10)HUKW0534 Lot Number: HUJY0302 HUJY1095 HUJZ1332 HUJZ1336 HUJZ1339 HUJZ1340 HUKR1349 HUKR1364 HUKS0784 HUKS0806 HUKS1217 HUKS1218 HUKU0259 HUKU0351 HUKV0349 HUKV0567 HUKW0534 Product Name:Hickman 12.5 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600650 UDI code: (01)00801741051975(17)300228(10)HUKQ0535 (01)00801741051975(17)300428(10)HUKS1474 (01)00801741051975(17)300428(10)HUKS1483 (01)00801741051975(17)300628(10)HUKU0313 (01)00801741051975(17)300628(10)HUKU0317 (01)00801741051975(17)300628(10)HUKU0328 (01)00801741051975(17)300728(10)HUKV0354 (01)00801741051975(17)300728(10)HUKV0371 (01)00801741051975(17)300828(10)HUKW0171 (01)00801741051975(17)300828(10)HUKW1283 Lot Number: HUKQ0535 HUKS1474 HUKS1483 HUKU0313 HUKU0317 HUKU0328 HUKV0354 HUKV0371 HUKW0171 HUKW1283 Product Name:Hickman 10 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 606560 UDI code: (01)00801741052019(17)290828(10)HUKR1370 (01)00801741052019(17)290928(10)HUKS1219 (01)00801741052019(17)300128(10)HUKU0255 (01)00801741052019(17)290928(10)HUKU0324 (01)00801741052019(17)300128(10)HUKV0578 (01)00801741052019(17)300128(10)HUKW0172 (01)00801741052019(17)300128(10)HUKW1315 Lot Number: HUKR1370 HUKS1219 HUKU0255 HUKU0324 HUKV0578 HUKW0172 HUKW1315 Product Name:Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600100CE UDI code: (01)00801741051708(17)300628(10)HUKU0307 (01)00801741051708(17)300828(10)HUKW1312 Lot Number: HUKU0307 HUKW1312 Product Name:Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600310CE 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:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600520CE 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)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 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: 0600540CE 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)HUKW0156 (01)00801741051821(17)300328(10)HUKW0159 Lot Number: HUKR0064 HUKR0065 HUKR0067 HUKU0252 HUKU0270 HUKU0279 HUKU0308 HUKU0334 HUKV0359 HUKV0550 HUKW0156 HUKW0159 Product Name:Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600560CE 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)HUKV0555 Lot Number: HUKS0776 HUKS0816 HUKS1220 HUKU0302 HUKU0311 HUKU0345 HUKU0350 HUKV0555 Product Name:Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600570CE 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)300128(10)HUKS0774 (01)00801741051869(17)300128(10)HUKU0238 (01)00801741051869(17)300128(10)HUKU0242 (01)00801741051869(17)300128(10)HUKU0247 (01)00801741051869(17)300128(10)HUKU0253 (01)00801741051869(17)300128(10)HUKU0254 (01)00801741051869(17)300128(10)HUKU0266 (01)00801741051869(17)300128(10)HUKU0280 (01)00801741051869(17)300128(10)HUKU0283 (01)00801741051869(17)300128(10)HUKU0284 (01)00801741051869(17)300128(10)HUKU0290 (01)00801741051869(17)300128(10)HUKU0293 (01)00801741051869(17)300128(10)HUKU0294 (01)00801741051869(17)300128(10)HUKU0298 (01)00801741051869(17)300128(10)HUKU0312 (01)00801741051869(17)300128(10)HUKU0339 (01)00801741051869(17)300328(10)HUKU0340 (01)00801741051869(17)300128(10)HUKU0344 (01)00801741051869(17)300128(10)HUKU0354 (01)00801741051869(17)300328(10)HUKV0549 (01)00801741051869(17)300328(10)HUKV0576 (01)00801741051869(17)300328(10)HUKW0148 Lot Number: HUKR1342 HUKR1344 HUKR1346 HUKR1347 HUKR1348 HUKR1356 HUKR1363 HUKR1367 HUKR1368 HUKS0774 HUKU0238 HUKU0242 HUKU0247 HUKU0253 HUKU0254 HUKU0266 HUKU0280 HUKU0283 HUKU0284 HUKU0290 HUKU0293 HUKU0294 HUKU0298 HUKU0312 HUKU0339 HUKU0340 HUKU0344 HUKU0354 HUKV0549 HUKV0576 HUKW0148 Product Name:Hickman 12 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600620CE UDI code: (01)00801741051913(17)291028(10)HUJY0302 (01)00801741051913(17)291028(10)HUJY1095 (01)00801741051913(17)291128(10)HUJZ1332 (01)00801741051913(17)291128(10)HUJZ1336 (01)00801741051913(17)291128(10)HUJZ1339 (01)00801741051913(17)291128(10)HUJZ1340 (01)00801741051913(17)300328(10)HUKR1349 (01)00801741051913(17)300328(10)HUKR1364 (01)00801741051913(17)300428(10)HUKS0784 (01)00801741051913(17)300428(10)HUKS0806 (01)00801741051913(17)300428(10)HUKS1217 (01)00801741051913(17)230428(10)HUKS1218 (01)00801741051913(17)300628(10)HUKU0259 (01)00801741051913(17)300628(10)HUKU0351 (01)00801741051913(17)300728(10)HUKV0349 (01)00801741051913(17)300728(10)HUKV0567 (01)00801741051913(17)300828(10)HUKW0534 Lot Number: HUJY0302 HUJY1095 HUJZ1332 HUJZ1336 HUJZ1339 HUJZ1340 HUKR1349 HUKR1364 HUKS0784 HUKS0806 HUKS1217 HUKS1218 HUKU0259 HUKU0351 HUKV0349 HUKV0567 HUKW0534 Product Name:Hickman 12.5 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600650CE UDI code: (01)00801741051975(17)300228(10)HUKQ0535 (01)00801741051975(17)300428(10)HUKS1474 (01)00801741051975(17)300428(10)HUKS1483 (01)00801741051975(17)300628(10)HUKU0313 (01)00801741051975(17)300628(10)HUKU0317 (01)00801741051975(17)300628(10)HUKU0328 (01)00801741051975(17)300728(10)HUKV0354 (01)00801741051975(17)300728(10)HUKV0371 (01)00801741051975(17)300828(10)HUKW0171 (01)00801741051975(17)300828(10)HUKW1283 Lot Number: HUKQ0535 HUKS1474 HUKS1483 HUKU0313 HUKU0317 HUKU0328 HUKV0354 HUKV0371 HUKW0171 HUKW1283 Product Name:Hickman 10 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0606560CE UDI code: (01)00801741052019(17)290828(10)HUKR1370 (01)00801741052019(17)290928(10)HUKS1219 (01)00801741052019(17)300128(10)HUKU0255 (01)00801741052019(17)290928(10)HUKU0324 (01)00801741052019(17)300128(10)HUKV0578 (01)00801741052019(17)300128(10)HUKW0172 (01)00801741052019(17)300128(10)HUKW1315 Lot Number: HUKR1370 HUKS1219 HUKU0255 HUKU0324 HUKV0578 HUKW0172 HUKW1315
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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