Skip to content

Medline Kits, trays, and packs labeled as follows recallZ-1125-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 15, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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 [email protected].

Recall details

Recall number
Z-1125-2024
Status
Open, Classified
Initiated by the company
Nov 15, 2023
Posted by the FDA
Feb 25, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
279 units
Product code
OKV
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

Product description

Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&C PACK, REF DYNJ67214G

Code information (models, lots, serial numbers)

a) REF CDS983911J, UDI/DI 40193489402668 (case), 10193489402667 (unit), Lot Numbers: 22EBU168, 22KBI115, 22LBL299, 22NBD200, 22NBF154, 23ABE617, 23ABU424, 23CBT642, 23IBM022, 23JBC180; b) REF DYNJ67214F, UDI/DI 40195327277803 (case), 10195327277802 (unit), Lot Numbers: 22LBT250, 23BBM551, 23CBS078; c) REF DYNJ67214G, UDI/DI 40195327411306 (case), 10195327411305 (unit), Lot Numbers: 23GBI555

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93800).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page