Recall archive / FDA device enforcement
Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter R... — FDA record Z-1051-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 4, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601700 9F Hickman CV Catheter Repair Kit 0601710 12F Hickman CV Catheter Repair Kit 0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601740 12.5F Hickman CV Catheter Repair Kit 0601750 10F Leonard CV Catheter Repair Kit 0601760 7F Hickman CV Catheter Repair Kit 0601790 10F Hickman CV Catheter Repair Kit
- Reason
- Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).
- Classification
- Class II
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 7520 (Breakdown: US 3764; OUS 3243)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1051-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog Numbers/Lot-Serial Numbers/UDI Code: 0601610 / REFX4541 / (01)00801741036385(17)230930(10)REFX4541 0601610 / REFX5636 / (01)00801741036385(17)240930(10)REFX5636 0601610 / REFY2820 / (01)00801741036385(17)230930(10)REFY2820 0601610 / REGP0198 / (01)00801741036385(17)241231(10)REGP0198 0601610 / REGP2720 / (01)00801741036385(17)250131(10)REGP2720 0601610 / REGQ1144 / (01)00801741036385(17)250228(10)REGQ1144 0601620 / REES0680 / (01)00801741074479(17)230430(10)REES0680 0601620 / REEU0726 / (01)00801741074479(17)230630(10)REEU0726 0601620 / REEU1536 / (01)00801741074479(17)230630(10)REEU1536 0601620 / REEU3300 / (01)00801741074479(17)230630(10)REEU3300 0601620 / REEV1906 / (01)00801741074479(17)230731(10)REEV1906 0601620 / REFX4543 / (01)00801741074479(17)230930(10)REFX4543 0601630 / REEQ0746 / (01)00801741036408(17)230228(10)REEQ0746 0601630 / REGN2382 / (01)00801741036408(17)241231(10)REGN2382 0601630 / REGQ1143 / (01)00801741036408(17)250228(10)REGQ1143 0601680 / REER3749 / (01)00801741036415(17)230331(10)REER3749 0601680 / REEU1626 / (01)00801741036415(17)230630(10)REEU1626 0601690 / REES0716 / (01)00801741036422(17)230131(10)REES0716 0601690 / REFX1172 / (01)00801741036422(17)230131(10)REFX1172 0601690 / REFY0874 / (01)00801741036422(17)230131(10)REFY0874 0601700 / REES2549 / (01)00801741036439(17)230430(10)REES2549 0601700 / REGQ1154 / (01)00801741036439(17)230731(10)REGQ1154 0601710 / REFY2852 / (01)00801741036446(17)231031(10)REFY2852 0601730 / REGQ1174 / (01)00801741036453(17)240229(10)REGQ1174 0601740 / REFZ0223 / (01)00801741036460(17)230930(10)REFZ0223 0601750 / REFY0744 / (01)00801741036477(17)230731(10)REFY0744 0601760 / REEU1534 / (01)00801741036484(17)230630(10)REEU1534 0601790 / REFW1651 / (01)00801741036514(17)231031(10)REFW1651 7741700 / REET0877 / (01)00801741036798(17)240131(10)REET0877 7741800 / REER0703 / (01)00801741036804(17)240531(10)REER0703 7741800 / REFW3156 / (01)00801741036804(17)250131(10)REFW3156 0601600 / REES06790 / (01)00801741036378(17)220831(10)REES0679 0601600 / REES2528 / (01)00801741036378(17)220831(10)REES2528 0601600 / REES3456 / (01)00801741036378(17)220831(10)REES3456 0601610 / REEQ1683 / (01)00801741036385(17)220831(10)REEQ1683 0601610 / REEQ4180 / (01)00801741036385(17)220831(10)REEQ4180 0601610 / REER3748 / (01)00801741036385(17)220831(10)REER3748 0601610 / REES0715 / (01)00801741036385(17)220831(10)REES0715 0601610 / REET3287 / (01)00801741036385(17)220831(10)REET3287 0601620 / REEQ2751 / (01)00801741074479(17)220831(10)REEQ2751 0601620 / REEQ4141 / (01)00801741074479(17)220831(10)REEQ4141 0601620 / REER3694 / (01)00801741074479(17)220831(10)REER3694 0601620 / REET3269 / (01)00801741074479(17)220831(10)REET3269 0601630 / REEU0729 / (01)00801741036408(17)220831(10)REEU0729 0601630 / REEU3297 / (01)00801741036408(17)220831(10)REEU3297 0601690 / REEU0727 / (01)00801741036422(17)220831(10)REEU0727 0601700 / REER3695 / (01)00801741036439(17)220831(10)REER3695 0601710 / REER3750 / (01)00801741036446(17)220831(10)REER3750 0601710 / REEU3314 / (01)00801741036446(17)220831(10)REEU3314 0601740 / REEU3298 / (01)00801741036460(17)220831(10)REEU3298 0601750 / REEU0730 / (01)00801741036477(17)220831(10)REEU0730 0601750 / REEU1608 / (01)00801741036477(17)220831(10)REEU1608 0601760 / REER3696 / (01)00801741036484(17)220831(10)REER3696 0601760 / REES3457 / (01)00801741036484(17)220831(10)REES3457 0601760 / REET2794 / (01)00801741036484(17)220831(10)REET2794 0601760 / REEU1184 / (01)00801741036484(17)220831(10)REEU1184 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide Distribution: U.S.(nationwide): AK, 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; OUS (foreign) countries of: Australia, Belgium, Canada, Hong Kong and Japan. O.U.S.: Australia, Belgium, Canada, Hong Kong, and Japan.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 8, 2023
- Recall initiation date
- Jan 4, 2023
- Center classification date
- Feb 1, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.