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

Reason

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

Status

Ongoing

Distribution

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…

Enforcement report date

Feb. 25, 2026

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)

Filed by

Bard Peripheral Vascular Inc

Product

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

Reason

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

Distribution pattern

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.

Quantity

14,935 units

Codes and lots

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…

The first 12,000 characters of this field; the agency record has the rest.

Recall started

Dec. 12, 2025

Voluntary or mandated

Voluntary: Firm initiated

Device type

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Root cause (FDA)

Process control

What the company told customers

On 01/12/1026, the firm sent via FedEx and/or email an "URGENT: Medical Device Product Removal" Letter informing customers that BD has identified via internal inspections that the packaging of some Hickman Catheter and Broviac Catheter kits may have damage present on the outer tray, potentially compromising the sterile barrier. Affected products were distributed between 06/12/2025 to 11/28/2025. Customers are instructed to: 1. Discontinue use of product listed in the letter and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process. 2. Share this notification with all users within their facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, forward this notification to ensure that these entities are contacted and informed of the recall. 3. Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not they have any of the product so that BD may acknowledge their receipt of this notification and subsequently process any required product credit. 4. Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of. For questions or assistance, contact: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com

Recall number

Z-1367-2026

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FDA device name: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Distributed in (FDA's record): Alabama Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Jersey New Mexico New York North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and nationwide

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement report, recall number Z-1367-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

FDA recall record Z-1367-2026, Feb. 25, 2026. "Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060." PlainRecords, https://plainrecords.com/recall/device/z-1367-2026/ (as of the day it was built).

At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections