Medline Kits recall: Sterility Concern
Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOSTOMY CARE TRAY, REF…
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 DYND40589, UDI/DI 40080196032823 (case), 10080196032822, (unit), Lot Numbers: 2022032590, 2022033190, 2022040190, 2022040790, 2022041490, 2022041890, 2022050690, 2022052090, 2022060990, 2022062990, 2022071390, 2022063090, 2022071590, 2022071290, 2022071890, 2022080290, 2022080190, 2022080390, 2022080590, 2022090890, 2022091290, 2022091490, 2022092990, 2022101790, 2022111490, 2022113090, 2022122390, 2023011190, 2023011390, 2023020690, 2023020790, 2023020990, 2023021090, 2023030990, 2023031090, 2023031490, 2023031690, 2023031790, 2023032190, 2023033190, 2023040490, 2023040390, 2023042590, 2023041090, 2023042790, 2023042690, 2023042890, 2023050190, 2023051990, 2023052590, 2023052490, 2023052690, 2023052790, 2023053090, 2023053190, 2023060990, 2023061390, 2023061490, 2023061690, 2023061790, 2023061590, 2023062890, 2023080190, 2023090490, 2023090590, 2023090890, 2023090690, 2023090790, 2023100490, 2023101190; b) REF DYNDA3004, UDI/DI 00653160355543 (case), 10653160355540, (unit), Lot Numbers: 2022122090; c) REF DYND40650, UDI/DI 40080196855293 (case), 10080196855292, (unit), Lot Numbers: 2022042290, 2022061790, 2022090290, 2022101290, 2022112990, 2023022190, 2023040690, 2023052590, 2023062690, 2023072790; d) REF DYND40594, UDI/DI 40080196032854 (case), 10080196032853, (unit), Lot Numbers: 2022032890, 2022071490, 2022090290, 2022092790, 2022111190, 2023021090, 2023080290, 2023090190
- Product
- Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA3004; c) TRACHEOSTOMY CARE TRAY, REF…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 991,744 units
- Distribution
- Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
- Recall date
- March 6, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)