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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
MEDLINE INDUSTRIES, LP - Northfield
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1128-2024

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