Medline Kits recall: Sterility Concern
MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT…
Why was Medline Kits recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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 (case), 10195327375713 (unit), Lot Numbers: 23DBC646, 23FBA039, 23GBA604, 23HBZ389, 23JBN556; n) REF DYNJ46216J; UDI/DI 40195327407491 (case), 10195327407490 (unit), Lot Numbers: 23EBF873, 23GBO919, 23GBT576, 23IBE145; o) REF CDS984899G; UDI/DI 40193489983822 (case), 10193489983821 (unit), Lot Numbers: 22CLA789; p) REF CDS984899I; UDI/DI 40195327313297 (case), 10195327313296 (unit), Lot Numbers: 23IBV180; q) REF DYNJ65475A; UDI/DI 40193489974578 (case), 10193489974577 (unit), Lot Numbers: 22DBF905; r) REF DYNDC2213F; UDI/DI 40195327052080 (case), 10195327052089 (unit), Lot number: 22ABM936, 22CMG684, 22EMB991; s) REF CDS984895I; UDI/DI 40193489983815 (case), 10193489983814 (unit), Lot Number: 22FBL382, 22IBD790, 23ABM451, 23DBM334; t) REF DYNJ36719C; UDI/DI 40193489265539 (case), 10193489265538 (unit), Lot Numbers: 21LBA818, 21LBU235, 22BBL912; u) REF DYNJ906741B; UDI/DI 40195327055364 (case), 10195327055363 (unit), Lot Numbers: 22ABF704, 22ABL214, 22BBQ966, 22FBY564, 22GBQ902, 22HMI302, 23AMA387, 23AMI317; v) REF CDS983362C; UDI/DI 40193489267342 (case), 10193489267341 (unit), Lot Numbers: 23ABI733; w) REF DYNJ33112I; UDI/DI 40193489402736 (case), 10193489402735 (unit), Lot Numbers: 22DBO140, 22DBO155, 22JBY668, 23BBT134, 23DBT051, 23EBA549, 23HBI328, 23IBM005; x) REF CDS980272L; UDI/DI 40193489616331 (case), 10193489616330 (unit), Lot Numbers: 22NBC732; y) REF DYNDJN001A; UDI/DI 40193489421614 (case), 10193489421613 (unit), Lot Numbers: 22EBB217, 22FBQ070, 22FBU496
- Product
- MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Distribution
- Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
- Recall date
- March 6, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)