FDA-Device2026-01-21Class IIPROCESSING DEFECT

Medline DR HOLCOMB FACIAL PACK kits recalled for stuck IV check valve

OTHERNationwide distribution

Stop using Medline DR HOLCOMB FACIAL PACK kits

Medline kits labeled DR HOLCOMB FACIAL PACK (SKU DYNJ54488A) contain B. Braun IV Administration Sets with check valve components that may become stuck in the open or closed position. This can prevent proper fluid flow during IV administration. The recall affects 16 units distributed nationwide.

  • Stop using the Medline DR HOLCOMB FACIAL PACK kit immediately if you have it
  • Check the lot number 25HBQ850 on your kit
  • Contact Medline or your healthcare provider for replacement or proper disposal instructions
Hazard

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.

Sold states
US Nationwide distribution.
Affected count
16 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1054-2026

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