Class II U.S. Food and Drug Administration

Medline Kits containing B. Braun IV Administration Sets and Pump recall: Medline kits contain B. Braun IV Administration Sets and Pump Administration

Recall published 9 months ago

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.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1050-2026
Published
January 21, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
633 units
Distribution
Nationwide
Made in
United States
Lot / code info
Medline SKU PHS972096014B, UDI/DI 10889942695911 (EA) 40889942695912 (CS), Lot Number 25GBY100; Medline SKU CDS984289O, UDI/DI 10198459418143 (EA) 40198459418144 (CS), Lot Number 25HBI736; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBL296; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBN030; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25HLA445; Medline SKU DYKM1025D, UDI/DI 10195327482893 (EA) 40195327482894 (CS), Lot Number 25HMA140; Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IBI197; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IBL774; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IMG620; Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IMH657; Medline SKU PHS972012D, UDI/DI 10193489571875 (EA) 40193489571876 (CS), Lot Number 25IMH924; Medline SKU DYNJ905557B, UDI/DI 10193489468243 (EA) 40193489468244 (CS), Lot Number 25JBH529; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25JBO555; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25JLA937; Medline SKU CDS984355K, UDI/DI 10198459258848 (EA) 40198459258849 (CS), Lot Number 25KBB119; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512.
UPC codes
10889942695911, 40889942695912, 10198459418143, 40198459418144, 10198459316593, 40198459316594, 10195327461294, 40195327461295, 10195327482893, 40195327482894, 10193489432794, 40193489432795, 10193489571875, 40193489571876, 10193489468243, 40193489468244, 10198459258848, 40198459258849

Products covered by this recall

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O; 5) OPEN HEART CDSKit SKU DYNJ902879T; 6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F; 7) OPEN HEART CDSKit SKU DYNJ905557B; 8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.

Check your product

The notice names 53 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10889942695911
  • 40889942695912
  • 10198459418143
  • 40198459418144
  • 10198459316593
  • 40198459316594
  • 10195327461294
  • 40195327461295
  • 10195327482893
  • 40195327482894
  • 10193489432794
  • 40193489432795
  • 10193489571875
  • 40193489571876
  • 10193489468243
  • 40193489468244
  • 10198459258848
  • 40198459258849

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25GBY100
  • 25HBI736
  • 25HBL296
  • 25HBN030
  • 25HLA445
  • 25HMA140
  • 25IBI197
  • 25IBL774
  • 25IMG620
  • 25IMH657
  • 25IMH924
  • 25JBH529
  • 25JBO555
  • 25JLA937
  • 25KBB119
  • 25KBH512
  • 25KBH512. — 633 units

Model or item number

On the rating label, the box or the instruction sheet.

  • CDS984289O
  • CDS984355K
  • DYKM1025D
  • DYNJ0394752O
  • DYNJ902879T
  • DYNJ903523F
  • DYNJ905557B
  • UDI
  • DI 108
  • DI 10198459418143
  • DI 10198459316593
  • DI 10195327461294
  • DI 10195327482893
  • DI 10193489432794
  • PHS972012D
  • DI 10193489571875
  • DI 10193489468243
  • DI 10198459258848

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10889942695911, 40889942695912, 10198459418143; lot code 25GBY100, 25HBI736, 25HBL296; model number CDS984289O, CDS984355K, DYKM1025D. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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