Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Reason for recall: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile. Distribution: Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama Quantity: 3900 units Lot/code info: a) REF DYNDA2863, UDI/DI 40195327008025 (case), 10195327008024 (unit), Lot Numbers: 22ABQ171, 22ABT619, 22IBG373; b) REF DYNDA2863H, UDI/DI 40195327008025 (case), 10195327008024 (unit), Lot Numbers: 22ABQ171, 22ABT619, 22IBG373; c) REF DYNDV2518, UDI/DI 40195327089079 (case), 10195327089078 (unit), Lot Numbers: 22GBA169, 22HBU208; d) REF DYNDV2518H, UDI/DI 40195327089079 (case), 10195327089078 (unit), Lot Numbers: 22GBA169, 22HBU208; e) REF DYNDV2445, UDI/DI 20193489110576 (case), 10193489110579 (unit), Lot Numbers: 2022012480; f) REF EBSI1306A, UDI/DI 00653160352122 (case), 10653160352129 (unit), Lot Numbers: 2022042850; g) REF BSIPIV1010, UDI/DI 00653160349153 (case), 10653160349150 (unit), Lot Numbers: 2022020750, 2022040480, 2022082980; h) REF DYNDV2465, UDI/DI 20193489110163 (case), 10193489110166 (unit), Lot Numbers: 2022031480, 2022041880
40195327008025, 10195327008024, 40195327089079, 10195327089078, 20193489110576, 10193489110579, 00653160352122, 10653160352129, 00653160349153, 10653160349150, 20193489110163, 10193489110166
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.