The Recall Desk
SevereFDA (Devices)·Z-0765-2025·Announced 2025-01-22

Medline Fluid Delivery Sets Recalled Due to Assembly Error

Medline Fluid Delivery Sets were incorrectly assembled with macro drip chambers instead of required micro drip chambers. The macro chamber delivers three times more fluid per drop, creating a risk of dosing errors.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I medical device recall. The assembly error affects fluid delivery rates in clinical settings, which could result in serious adverse health consequences. No illnesses or injuries have been reported to date.

Plain-English summary

Medline Industries has recalled 3930 Fluid Delivery Sets with Drip Chambers due to an assembly error. The affected sets were incorrectly manufactured with white macro drip chambers instead of the required grey micro drip chambers. Because a macro drip chamber delivers three times more fluid per drop than a micro drip chamber, this error could result in incorrect fluid or medication delivery rates in clinical settings.

The recall affects multiple item numbers distributed nationwide. Healthcare facilities and patients who use these sets should stop using the affected units and verify item numbers and lot numbers against the FDA recall notice. Organizations can reference the detailed list of item numbers, UDI codes, and lot numbers provided by the FDA and Medline Industries to identify affected products.

No illnesses or injuries have been reported at this time. Users should contact Medline Industries or their healthcare facility's supply chain for instructions on return or replacement of affected units.

The recalled product

Product
Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341; 3) MTO,ANGIO,SINGLE,SPIKE,KIT, Item Number: 65232486; 4) MTO,ANGIO,SINGLE,SPIKE,KIT,GOOD,SAM, Item
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device
Hazard
  • assembly-defect
  • dosing-error

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)

  • 1) 60130527 UDI-D:10193489046465(each)
  • 20193489046462(case)
  • Lot Number:0000133032
  • 2) 65111341 UDI-D:10193489061314(each)
  • 20193489061311(case)
  • Lot Number:0000129541
  • 3) 65111341 UDI-D:10193489061314(each)
  • Lot Number:0000134701
  • 4) 65232486 UDI-D:10193489063950(each)
  • 20193489063957(case)
  • Lot Number:0000129544
  • 5) 65232486 UDI-D:10193489063950(each)
  • Lot Number:0000128715
  • 6) 65232486 UDI-D:10193489063950(each)
  • Lot Number:0000133060
  • 7) 65232486 UDI-D:10193489063950(each)
  • Lot Number:0000131657
  • 8) 65232486 UDI-D:10193489063950(each)
  • Lot Number:0000135723
  • 9) 65232486 UDI-D:10193489063950(each)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category