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Medline convenience kits containing BD Insyte Autoguard… recallZ-2043-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated May 23, 2025

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 issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 05/23/2025 via email and USPS mail. The notice explained the issue, risk, and requested the following: "REQUIRED ACTION: 1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all 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.Website link: https://recalls.medline.comRecall Reference #: R-25-106-FGX2Recall Code: 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 and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.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. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]."

Recall details

Recall number
Z-2043-2025
Status
Open, Classified
Initiated by the company
May 23, 2025
Posted by the FDA
Jun 30, 2025
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
186 units
Product code
LRO
Distribution
US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.

Product description

Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC010627; 6) DRAWER 3, REF ACC010898.

Code information (models, lots, serial numbers)

1) REF ACC010254B: UDI/DI 10193489651683 (each), 40193489651684 (case), Lot Number: 24LDA269; 2) REF ACC010256: UDI/DI 10884389559529 (each), 40884389559520 (case), Lot Number: 24LDA106; 3) REF ACC010316A: UDI/DI 10889942831746 (each), 40889942831747 (case), Lot Number: 24LDA823; 4) REF ACC010389C: UDI/DI 10193489472493 (each), 40193489472494 (case), Lot Number: 24LDB092; 5) REF ACC010627: UDI/DI 10195327226589 (each), 40195327226580 (case), Lot Number: 24LDA268; 6) REF ACC010898: UDI/DI 10198459192074 (each), 40198459192075 (case), Lot Number: 24LDA260.

Devices named in this recall

6 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 97027).

Sources and updates

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