SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
Check against the official notice below — it lists the full affected range.
Bard Peripheral Vascular Inc. is recalling 3,240 SAFE-T PLUS ATRAUMATIC ADULT LP TRAY devices due to manometer failure that can cause leaking and mating issues. The affected trays were distributed nationwide across all U.S. states plus Puerto Rico, as well as internationally to Costa Rica and Hong Kong. The recalled devices are identified by Catalog Number 4306CWSP with specific lot numbers ranging from 0001416832 through 0001436145, with expiration dates between April 2022 and September 2022.
The manometer failure in these lumbar puncture trays could compromise their proper function during medical procedures. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Reason for recall: Due to lumbar puncture tray manometer failure mode of leaking and mating issues. 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. Quantity: 3,240 devices Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.