Z-0793-2022 Class II Ongoing
FDA device recall Z-0793-2022 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: 1260 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 23, 2022
- Initiation Date
- Jan 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1260 devices
Product Description
ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
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: 4301CDF Lot Numbers/UDI (GTIN, DI + PI): 0001433537 (01)10885403231810(17)260831(10)0001433537 0001437269 (01)10885403231810(17)260930(10)0001437269
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0793-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026