Recall archive / FDA device enforcement
SAFE-T PLUS ATRAUMATIC ADULT LP TRAY — FDA record Z-0800-2022
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 ATRAUMATIC ADULT LP TRAY
- Reason
- Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
- Classification
- Class II
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 3,240 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0800-2022
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: 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 |
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.