Z-1161-2023Class II

Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon...

Name: Z-1161-2023 Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-12-27
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-12-27 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with... on 2022-12-27. FDA classified it as Class II and gives the reason as "The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1161-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-27
Posted: 2023-02-23
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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;
Product code: FCH Tray, Biopsy, Without Biopsy Instruments
Reason for recall: The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 4,360 trays
Distribution: US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1161-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1161-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-23
Z-1162-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-23
Z-1163-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-23

Product code FCH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)