MEDLINE INDUSTRIES, LP - Northfield: Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; c) PRE OP KIT 1, REF DYKS1377; d) PRE OP KIT 1, R

Hazard

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.

Details from the source

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: 1270 units Lot/code info: a) REF DYNJ69664, UDI/DI 40193489966337 (case), 10193489966336 (unit), Lot Numbers: 21LBW095, 22EBT126, 22HBQ767, 22LBB063, 23EBF143; b) REF DYNJ81659A, UDI/DI 40195327277094 (case), 10195327277093 (unit), Lot Numbers: 22KBK040; c) REF DYKS1377, UDI/DI 40195327216673 (case), 10195327216672 (unit), Lot Numbers: 22LLA282; d) REF DYKS1377A , UDI/DI 40195327216673 (case), 10195327216672 (unit), Lot Numbers: 23BLA389

UPC codes

40193489966337, 10193489966336, 40195327277094, 10195327277093, 40195327216673, 10195327216672

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.