| | Class 2 Device Recall Broviac |  |
| Date Initiated by Firm | December 12, 2025 |
|---|
| Date Posted | February 13, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1367-2026 |
|---|
| Recall Event ID |
98222 |
| 510(K)Number | K830233 K830256 |
|---|
| Product Classification |
Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
|
| Product | Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060 |
|---|
| Code Information |
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
|
| FEI Number |
2020394
|
Recalling Firm/
Manufacturer |
Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
850 W. Rio Salado Prkwy.
Tempe AZ 85281-2438
|
| For Additional Information Contact |
480-303-2602 |
|---|
Manufacturer Reason
for Recall | Due to damage to outer tray that can potentially compromise the sterile barrier |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | 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 |
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| Quantity in Commerce | 14,935 units |
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| 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 WV. The countries of Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, Vietnam. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LJS
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