Z-1128-2024 Class I Ongoing
FDA device recall Z-1128-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on November 15, 2023 and is designated Class I. 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 Irrigatio… The recall status is ongoing. Affected quantity: 1,012,700 units.
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
- 1,012,700 units
Product Description
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
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 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