The Recall Desk
HighFDA (Devices)·Z-1050-2026·Announced 2026-01-21

[pending] Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:

Pending LLM rewrite. Source: FDA_DEVICE Z-1050-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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 recalled product

Product
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 DYNJ0394752
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • 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
  • Lot Number 25IBL774

Distribution

Distributed nationwide across the United States.

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