Z-0800-2022 Class II Ongoing
FDA device recall Z-0800-2022 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: 3,240 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 23, 2022
- Initiation Date
- Jan 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,240 devices
Product Description
SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
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: 4306CWSP Lot Numbers/UDI (GTIN, DI + PI): 0001416832 (01)10885403229008(17)220430(10)0001416832 0001417843 (01)10885403229008(17)220430(10)0001417843 0001421009 (01)10885403229008(17)220531(10)0001421009 0001424764 (01)10885403229008(17)220630(10)0001424764 0001428872 (01)10885403229008(17)220630(10)0001428872 0001436145 (01)10885403229008(17)220930(10)0001436145
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0800-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026