FDA recall, , Moderate risk
Bard Broviac Single-Lumen CV Catheter Cutdown Tray
The Broviac catheter tray has damage to its outer tray that can compromise the sterile barrier.
Summary by Recall Canary from the FDA notice
What happened
Bard Peripheral Vascular Inc, of Tempe, Arizona, recalled the Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060 because damage to the outer tray can potentially compromise the sterile barrier. The company began the recall on December 12, 2025, and the FDA added it to its Enforcement Report and classified it on February 13, 2026.
The recalled product was distributed worldwide, including nationwide in the United States and in countries such as Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, and Vietnam.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
- UDI-DI
- 00801741051692
- 00801741051708
- 00801741051715
- 00801741051739
- 00801741051777
- 00801741051807
- 00801741051821
- 00801741051845
- 00801741051869
- 00801741051913
- 00801741051975
- 00801741052019
- Lot code
- HUKV0547
- 6.6
- HUKU0307
- HUKW1312
- HUKU0274
- HUKS0783
- HUKU0250
- HUKU0310
- HUKR1359
- HUKS0811
- HUKU0316
- 4.2
- HUKS1468
- HUKU0246
- HUKU0278
- HUKU0289
- HUKU0305
- HUKU0327
- HUKU0338
- HUKU0353
- HUKW0164
- HUKW1278
- HUKW1285
- HUKR0064
- HUKR0065
- HUKR0067
- HUKU0252
- HUKU0270
- HUKU0279
- HUKU0308
- HUKU0334
- HUKV0359
- HUKV0550
- HUKV0560
- HUKW0156
- HUKW0159
- 9.6
- HUKS0776
- HUKS0816
- HUKS1220
- HUKU0302
- HUKU0311
- HUKU0345
- HUKU0350
- HUKV0376
- HUKV0555
- 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
- HUJY0302
- HUJY1095
- HUJZ1332
- HUJZ1336
- HUJZ1339
- HUJZ1340
- HUKR1349
- HUKR1364
- HUKS0784
- HUKS0806
- HUKS1217
- HUKS1218
- HUKU0259
- HUKU0351
- HUKV0349
- HUKV0567
- HUKW0534
- 12.5
- HUKQ0535
- HUKS1474
- HUKS1483
- HUKU0313
- HUKU0317
- HUKU0328
- HUKV0354
- HUKV0371
- HUKW0171
- HUKW1283
- HUKR1370
- HUKS1219
- HUKU0255
- HUKU0324
- HUKV0578
- HUKW0172
- HUKW1315
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, PR, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, and West Virginia. The countries of Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, Vietnam.
- Company
- Bard Peripheral Vascular IncTempe, Arizona
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98222
- Recall number
- Z-1367-2026
- Quantity recalled
- 14,935 units
All recalls from Bard Peripheral Vascular Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
