Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471; c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442; d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472; e) KIT,SUCTION CATH,18FR W/H20, REF DYND41474; f) KIT,SUCTION CATH,6FR,DELEE,W/H, REF DYND41476; g) KIT,SUCTION CATH,8FR DELEE W/H, REF DYND41478; h) KIT,SUCTION CATHETER,14FR W/S, REF DYND41442
This recall is currently active, issued February 25, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- November 15, 2023
- Posted
- February 25, 2024
- Recall Number
- Z-1128-2024
- Quantity
- 1,012,700 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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 DYND41470, UDI/DI 40080196033608(case), 10080196033607(unit), Lot Numbers: 2022042690, 2022070690, 2022090790, 2022102590, 2023051790; b) REF DYND41471, UDI/DI 40080196033622(case), 10080196033621(unit), Lot Numbers: 2022070190, 2022072890, 2022101090, 2022121390, 2022121990, 2023022890, 2023051890; c) REF DYND40442, UDI/DI 40080196032618(case), 10080196032617(unit), Lot Numbers: 2022040590, 2022051890, 2022072290, 2022090690, 2022100790, 2022093090, 2022101190, 2022122890, 2023051290, 2023060590, 2023080290, 2023092690; d) REF DYND41472, UDI/DI 40080196996538(case), 10080196996537(unit), Lot Numbers: 2022042590, 2022062390, 2022070590, 2022072590, 2022080890, 2022082590, 2023010690, 2023022790, 2023030890, 2023041090, 2023041990, 2023070590; e) REF DYND41474, UDI/DI 40080196033653(case), 10080196033652(unit), Lot Numbers: 2022082390, 2022101090, 2022121290, 2022122090, 2023030390, 2023070590, 2023092590; f) REF DYND41476, UDI/DI 40080196033660(case), 10080196033669(unit), Lot Numbers: 2022062290, 2022072890, 2022102490, 2022122090, 2023030190, 2023051990; g) REF DYND41478, UDI/DI 40080196033677(case), 10080196033676(unit), Lot Numbers: 2022042890, 2022070690, 2022082390, 2022100690, 2022121290, 2023010490, 2023041490, 2023080890, 2023092590; h) REF DYND41442, UDI/DI 40080196033578(case), 10080196033577(unit), Lot Numbers: 2022031590, 2022032290, 2022042790, 2022060290, 2022053190, 2022052790, 2022060690, 2022072690, 2022072790, 2022082490, 2022102490, 2023012490, 2023030390, 2023032390, 2023032490, 2023041790, 2023060190, 2023060290, 2023070590
Root Cause
Nonconforming Material/Component
Action Taken
MEDLINE issued an IMMEDIATE ACTION REQUIRED NURSE ASSIST PRODUCT RECALL notice to its consignees on 11/16/2023 via USPS first class mail and email. The notice explained the problem, requested log on to their portal to identify the products and check their inventory so the product could be quarantined. Once Medline receives the completed response form, over-labels will be shipped to the consignee. Medline Industries, LP instructed customers to over-label the convenience kits with a warning label indicating to remove the sodium chloride irrigation or Sterile water and replace from a different sterile supply. Distributors or consignees who further distributed the affected products were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.