Z-1119-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2024
- Initiation Date
- November 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 991,744 units
Product Description
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 DYND40650; d) TRAY,TRACH,W/PCLNR,14FR CATH N, REF DYND40594
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 Pattern
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Code Information
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