Z-0790-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 23, 2022
- Initiation Date
- January 20, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,400 devices
Product Description
Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
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: 4302CSP Lot Numbers/UDI (GTIN, DI + PI): 0001412493 (01)10885403107788(17)220331(10)0001412493 0001415324 (01)10885403107788(17)220430(10)0001415324 0001416351 (01)10885403107788(17)220430(10)0001416351 0001417052 (01)10885403107788(17)220430(10)0001417052 0001417550 (01)10885403107788(17)220430(10)0001417550 0001421010 (01)10885403107788(17)220531(10)0001421010 0001422378 (01)10885403107788(17)220630(10)0001422378 0001425085 (01)10885403107788(17)220630(10)0001425085 0001426188 (01)10885403107788(17)220630(10)0001426188 0001426941 (01)10885403107788(17)220630(10)0001426941 0001428873 (01)10885403107788(17)220630(10)0001428873 0001431044 (01)10885403107788(17)220630(10)0001431044 0001433024 (01)10885403107788(17)220831(10)0001433024 0001433846 (01)10885403107788(17)220930(10)0001433846 0001437468 (01)10885403107788(17)221031(10)0001437468 0001438331 (01)10885403107788(17)221031(10)0001438331 0001439310 (01)10885403107788(17)221031(10)0001439310 0001440531 (01)10885403107788(17)221031(10)0001440531