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

Z-0797-2022 Class II Ongoing

Recalled by Bard Peripheral Vascular Inc — Tempe, AZ

FDA device recall Z-0797-2022 was initiated by Bard Peripheral Vascular Inc on Jan 20, 2022 and is designated Class II. Reason for recall: Due to lumbar puncture tray manometer failure mode of leaking and mating issues. The recall status is ongoing. Affected quantity: 15,650 devices.

Recall Details

Product Type
Devices
Report Date
Mar 23, 2022
Initiation Date
Jan 20, 2022
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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0797-2022
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources