Z-1119-2024 Class I Ongoing

Recalled by MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

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