FDA-Device2026-01-21Class IIPROCESSING DEFECT

Medline surgical kits recalled for faulty IV administration set check valves

OTHERNationwide distribution

Stop using affected Medline surgical kits

Medline surgical kits containing B. Braun IV administration sets may have check valve components that become stuck in the open or closed position. This could affect fluid delivery during medical procedures. About 96 kits are affected.

  • Check if you have Medline kit SKU DYNJ0785864R or DYNJ0792607R
  • If you have either kit, stop using it immediately
  • Contact Medline or your healthcare facility for a replacement
  • Review lot numbers 25HMB184 or 25JMH400 on your kits
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
96 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: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1052-2026

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