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FDA (Device enforcement)Recalled 2023-11-15class i

MEDLINE INDUSTRIES, LP - Northfield: MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT, REF DYKE1718B

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 Lot/code info: a) REF CDS983682F; UDI/DI 40193489852975 (case), 10193489852974 (unit), lot Numbers: 22DDA235, 22GBJ113, 23ABQ437, 23EBS939; b) REF DYKE1718A; UDI/DI 40193489494656 (case), 10193489494655 (unit), Lot Numbers: 22FBU098, 22HBM601, 23ABM389; c) REF DYKE1718B; UDI/DI 40195327240128 (case), 10195327240127 (unit), Lot Numbers: 23DBE977; d) REF DYNDC2214G; UDI/DI 40195327051984 (case), 10195327051983 (unit), Lot Numbers: 22ABP471, 22BBO794, 22OBJ991; e) REF DYNJ55334C; UDI/DI 40889942703211 (case), 10889942703210 (unit), Lot Numbers: 22ABL051, 22EBV190, 22FBS394, 23BBA777, 23GBL169; f) REF DYNJ45175B; UDI/DI 40889942485216 (case), 10889942485215 (unit), Lot Numbers: 22CLB148, 22GLB002; g) REF DYNJ59030A; UDI/DI 40195327026203 (cases), 10195327026202 (unit), Lot Numbers: 22DBR838, 22EBO071, 22JBW765, 23FBF261, 23GBC456, 23HBR618; h) REF DYNJ83416; UDI/DI 40195327265053 (cases), 10195327265052 (unit), Lot Numbers: 22LBF471, 23ABN102, 23BBA471; i) REF MNS2895; UDI/DI 50653160062934 (case), 653160062939 (unit), Lot Numbers: 23BBQ180, 23DBN766, 23EBH195, 23FBE540; j) REF MNS2895H; UDI/DI 50653160062934 (case), 653160062939 (unit), Lot Numbers: 23BBQ180, 23DBN766, 23EBH195, 23FBE540; k) REF DYNJ60166C; UDI/DI 40193489467148 (case), 10193489467147 (unit), Lot Numbers: 23ELB099; l) REF CDS983910K; UDI/DI 40195327256594 (case), 10195327256593 (unit), Lot Numbers: 22JBT244, 23ABP271, 23ABP272, 23ABQ792, 23CBE912, 23DBR779, 23FBB371, 23JBL006, 23JBR337; m) REF DYNJ68872C; UDI/DI 40195327375714

UPC codes

40193489852975, 10193489852974, 40193489494656, 10193489494655, 40195327240128, 10195327240127, 40195327051984, 10195327051983, 40889942703211, 10889942703210, 40889942485216, 10889942485215, 40195327026203, 10195327026202, 40195327265053, 10195327265052, 50653160062934, 653160062939, 40193489467148, 10193489467147, 40195327256594, 10195327256593, 40195327375714, 10195327375713, 40195327407491, 10195327407490, 40193489983822, 10193489983821, 40195327313297, 10195327313296, 40193489974578, 10193489974577, 40195327052080, 10195327052089, 40193489983815, 10193489983814, 40193489265539, 10193489265538, 40195327055364, 10195327055363

Source

Official record: FDA (Device enforcement)

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

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