The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
Reason for recall: The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile. Distribution: US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL. Quantity: 8250 units Lot/code info: UDI/DI 40889942574491 (case), 10889942574490 (each), Lot numbers: 22LBL675, 22JBR599, 22IBS045, 22GBT655, 22DBN398, 22DBD250, 22DBA001, 21LBN032, 21JBA478, 21EBE405
40889942574491, 10889942574490
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.