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MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in… recallZ-0163-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Sep 30, 2022

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 received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline disseminated MEDICAL DEVICE RECALL notice by US mail on 09/30/2022, The notices explained the issue and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-149-FG Recall Code: RXXXXXXX 3.Upon completion of the form, please destroy affected product. Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704."

Recall details

Recall number
Z-0163-2023
Status
Open, Classified
Initiated by the company
Sep 30, 2022
Posted by the FDA
Nov 1, 2022
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
40 kits
Product code
LRO
Distribution
US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.

Product description

MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures.

Code information (models, lots, serial numbers)

GTIN (01) 40195327002535, Lot Number 22DBJ856

Devices named in this recall

1 device 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 90946).

Sources and updates

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