PlainRecalls
FDA Devices Critical Class I Ongoing

Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W

Reported: March 6, 2024 Initiated: November 15, 2023 #Z-1110-2024

Product Description

Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W

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.

Details

Units Affected
2205 units
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 2205 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 6, 2024. Severity: Critical. Recall number: Z-1110-2024.