Recall archive / FDA device enforcement
SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT — FDA record Z-0794-2022
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 20, 2022. 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
- SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
- Reason
- Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
- Classification
- Class II
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 49,760 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0794-2022
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 Number: 4301CSP Lot Numbers/UDI (GTIN, DI + PI): 0001411297 (01)10885403107771(17)220331(10)0001411297 0001412994 (01)10885403107771(17)220331(10)0001412994 0001412993 (01)10885403107771(17)220331(10)0001412993 0001413312 (01)10885403107771(17)220331(10)0001413312 0001413224 (01)10885403107771(17)220331(10)0001413224 0001415321 (01)10885403107771(17)220430(10)0001415321 0001416350 (01)10885403107771(17)220331(10)0001416350 0001416833 (01)10885403107771(17)220430(10)0001416833 0001417546 (01)10885403107771(17)220430(10)0001417546 0001418031 (01)10885403107771(17)220430(10)0001418031 0001418108 (01)10885403107771(17)220430(10)0001418108 0001418415 (01)10885403107771(17)220430(10)0001418415 0001420365 (01)10885403107771(17)220430(10)0001420365 0001421922 (01)10885403107771(17)220630(10)0001421922 0001422603 (01)10885403107771(17)220630(10)0001422603 0001422916 (01)10885403107771(17)220630(10)0001422916 0001423132 (01)10885403107771(17)220630(10)0001423132 0001424769 (01)10885403107771(17)220630(10)0001424769 0001425084 (01)10885403107771(17)220630(10)0001425084 0001426503 (01)10885403107771(17)220630(10)0001426503 0001426326 (01)10885403107771(17)220630(10)0001426326 0001427017 (01)10885403107771(17)220630(10)0001427017 0001427227 (01)10885403107771(17)220630(10)0001427227 0001427711 (01)10885403107771(17)220630(10)0001427711 0001428496 (01)10885403107771(17)220630(10)0001428496 0001429509 (01)10885403107771(17)220630(10)0001429509 0001430610 (01)10885403107771(17)220630(10)0001430610 0001430605 (01)10885403107771(17)220630(10)0001430605 0001431471 (01)10885403107771(17)220630(10)0001431471 0001432426 (01)10885403107771(17)220831(10)0001432426 0001432425 (01)10885403107771(17)220831(10)0001432425 0001433266 (01)10885403107771(17)220831(10)0001433266 0001434250 (01)10885403107771(17)220930(10)0001434250 0001437530 (01)10885403107771(17)221031(10)0001437530 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
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
- Mar 23, 2022
- Recall initiation date
- Jan 20, 2022
- Center classification date
- Mar 16, 2022
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.