Home / Recalls / Bard Peripheral Vascular Inc / Z-0797-2022

Z-0797-2022 Class II Ongoing

Recalled by Bard Peripheral Vascular Inc — Tempe, AZ

Recall Details

Product Type
Devices
Report Date
March 23, 2022
Initiation Date
January 20, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15,650 devices

Product Description

SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT

Reason for Recall

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

Distribution Pattern

U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.

Code Information

Catalog Number: 4306CSP Lot Numbers/UDI (GTIN, DI + PI): 0001410708 (01)10885403107795(17)220331(10)0001410708 0001411191 (01)10885403107795(17)220331(10)0001411191 0001412491 (01)10885403107795(17)220331(10)0001412491 0001413309 (01)10885403107795(17)220331(10)0001413309 0001416352 (01)10885403107795(17)220430(10)0001416352 0001417049 (01)10885403107795(17)220430(10)0001417049 0001420356 (01)10885403107795(17)220430(10)0001420356 0001421923 (01)10885403107795(17)220630(10)0001421923 0001422376 (01)10885403107795(17)220630(10)0001422376 0001425371 (01)10885403107795(17)220630(10)0001425371 0001426677 (01)10885403107795(17)220630(10)0001426677 0001429128 (01)10885403107795(17)220630(10)0001429128 0001432172 (01)10885403107795(17)220630(10)0001432172 0001433264 (01)10885403107795(17)220831(10)0001433264 0001433845 (01)10885403107795(17)220930(10)0001433845 0001437662 (01)10885403107795(17)221031(10)0001437662

Other recalls by Bard Peripheral Vascular Inc

  • Z-1367-2026 Class II — Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrow (December 12, 2025)
  • Z-0887-2026 Class II — Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, (November 6, 2025)
  • Z-2638-2025 Class II — Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identif (August 21, 2025)
  • Z-1244-2025 Class I — Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 11 (February 5, 2025)
  • Z-0467-2025 Class II — Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 C (September 30, 2024)
  • Z-0371-2025 Class II — The EVSRF catheter is a sterile, single-use disposable medical device for endove (September 4, 2024)
  • Z-3206-2024 Class II — BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 (August 2, 2024)
  • Z-3062-2024 Class II — Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for (July 10, 2024)
  • Z-0676-2024 Class II — BD Recanalization System, REF: BDRECANSYSTEM (November 14, 2023)
  • Z-0643-2024 Class II — Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission (November 8, 2023)