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Medline brand, medical procedure convenience kits, labeled… recallZ-0721-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 6, 2024

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

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

FDA root cause category: Nonconforming Material/Component

What the company is doing

An IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification letter dated 11/7/24 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 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 response form. 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-209-FGX1 Recall Code: Recall Code 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. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-0721-2025
Status
Open, Classified
Initiated by the company
Nov 6, 2024
Posted by the FDA
Dec 20, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
318 kits
Product code
FDE
Distribution
US Nationwide. Canada.

Product description

Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A

Code information (models, lots, serial numbers)

UDI-DI: DYNJ21927R, 10195327104733(each), 40195327104734(case); Lot Number: 23IBF547 23GBT501 23FBU360 23EBU929 23EBL624 23EBA114 23CBN730 23ABF393 22JBK203 22IBN858 22HBO301 22GBC794 22CBI774; UDI-DI: DYNJ910120A, 10195327689872 (each), 40195327689873 (case), Lot Numbers: 24HMK254

Devices named in this recall

2 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 95806).

Sources and updates

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