MEDLINE INDUSTRIES, LP - Northfield: MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM

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: 3297 units Lot/code info: a) REF CDS983673G, UDI/DI 40193489951746 (case), 10193489951745 (unit), Lot Numbers: 22EDA378, 22EDB208; b) REF CDS983673I, UDI/DI 40195327147335 (case), 10195327147334 (unit), Lot Numbers: 22GBJ096, 22GBJ097, 22HBR769, 22KBN934, 23ABH521, 23ABM586, 23BBR709, 23DBL344; c) REF DYKM1425, UDI/DI 40889942511236 (case), 10889942511235 (unit), Lot Numbers: 22DLA695, 22FLA284, 22GLA016, 22ILA012, 22ILA463, 22KLA336, 23ALA341, 23BLA132, 23DLB048, 23ELA454, 23FLA774, 23HLA165, 23ILB030, 23JLA435; d) REF DT18700, UDI/DI 653160275087 (case), 10653160275084 (unit), Lot Numbers: 23EBC489; e) REF DYNJ53966A, UDI/DI 40889942964681 (case), 10889942964680 (unit), Lot Numbers: 23CMB869, 23DMG880, 23EMG449, 23FMC889, 23HMA233, 23IMD181; f) REF DYNJ53966AH, UDI/DI 40889942964681 (case), 10889942964680 (unit), Lot Numbers: 23CMB869, 23DMG880, 23EMG449, 23FMC889, 23HMA233, 23IMD181, g) REF CDS982034R, UDI/DI 40195327003740 (case), 10195327003739 (unit), Lot Numbers: 21LBB488, 21LBC635, 22HBW422; h) REF CDS982034S, UDI/DI 40195327295364 (case), 10195327295363(unit), Lot Numbers: 23ABB710, 23BBA114, 23EBB482; i) REF DYNJ39331B, UDI/DI 40889942731580 (case), 10889942731589 (unit), Lot Numbers: 22HBH194, 22JBE708, 22LBL321, 23GBV891, 23IBA384; j) REF DYNJ37709J, UDI/DI 40193489376075 (case), 10193489376074 (unit), Lot Numbers: 22FMG179; k) REF CDS983912V, UDI/DI 40195327057146 (case), 10195327057145 (unit), Lot Numbers: 22BBX974, 22DBG451, 22DBO438, 22FBM809; l) REF CDS983912W, UDI/DI 40195327238408 (

UPC codes

40193489951746, 10193489951745, 40195327147335, 10195327147334, 40889942511236, 10889942511235, 653160275087, 10653160275084, 40889942964681, 10889942964680, 40195327003740, 10195327003739, 40195327295364, 10195327295363, 40889942731580, 10889942731589, 40193489376075, 10193489376074, 40195327057146, 10195327057145, 40195327238408, 10195327238407, 40195327403141, 10195327403140, 40195327417827, 10195327417826, 40195327220991, 10195327220990, 40884389018324, 10884389018323, 40195327437566, 10195327437565, 40195327063819, 10195327063818, 40195327278022, 10195327278021, 40195327247387, 10195327247386, 40195327318858, 10195327318857

Source

Official record: FDA (Device enforcement) ↗

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