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Medline Kits containing B. Braun IV Administration Sets and… recallZ-1054-2026 · Medline Industries, LP · initiated Nov 26, 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 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 kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Medline issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/26/2025 via email and USPS first class mail. The notice explained the issue potential risk to the patient, and referred the consignee to the attached B Braun notice for further instructions. The B Braun notice provide "Interim Measures for Users" to provide for the continued use of the product. For questions, contact the Recall Department at 866-359-1704 or [email protected].

Recall details

Recall number
Z-1054-2026
Status
Open, Classified
Initiated by the company
Nov 26, 2025
Posted by the FDA
Jan 12, 2026
Recalling firm
Medline Industries, LP
Quantity
16 units
Product code
FTN
Distribution
US Nationwide distribution.

Product description

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A

Code information (models, lots, serial numbers)

UDI/DI 10193489587869 (EA) 40193489587860 (CS), Lot Number 25HBQ850

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 98154).

Sources and updates

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