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Medline Sterile Oncology Port Access Tray, Item #DYNDC2239… recallZ-1161-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Dec 27, 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

The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Recall letters dated 12/27/2022 were issued via email on 12/27/2022 or via U.S. mail for customers who haver not previously used the Medline Recall Portal. The customer was informed of the issue and told that any affected kits found are to be stickered with labels indicating to remove and replace the affected component from a different sterile supply and return the kit to the customer inventory. The remaining components are acceptable for use. If the customer has the affected kits, they are to indicate the quantity on the response and stickers will be sent to them for placement on the kits. The customer is requested to immediately check their stock for the affected item and lot numbers listed on the recall portal and quarantine the product. The customer is to use the website link in the letter to complete the response form. (The website link contains the specific item and lot numbers that are being recalled.) The quantity of affected product in inventory is to be reported on the response form. Upon receipt of the response form, the customer will receive over-labels via FedEx overnight to affix to the affected kits. If the customer is a distributor or the customer has resold or transferred the product to another company or individual, they are to notify their customer of the recall communication. These downstream customers are to return any affected product to the distributor (or to whoever resold/transferred the product) for collection and return to Medline.

Recall details

Recall number
Z-1161-2023
Status
Open, Classified
Initiated by the company
Dec 27, 2022
Posted by the FDA
Feb 23, 2023
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
4,360 trays
Product code
FCH
Distribution
US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.

Product description

Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;

Code information (models, lots, serial numbers)

UDI/DI (01) 40888277986412; Lot numbers 22OBD978, exp. 1/31/2023; 22HBR887, exp. 12/31/2023; 22GBD420, exp. 12/31/2023; 22EBK277, exp. 12/31/2023; 22EBK012, exp. 9/30/2023; 22EBA934, exp. 1/31/2024; 22ABK594, exp. 4/30/2023; 21KBS545, exp. 6/30/2022; and 21JBL152, exp. 2/28/2023.

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 91457).

Sources and updates

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