The Recall Desk
SevereFDA (Devices)·Z-0764-2025·Announced 2025-01-22

Medline Fluid Delivery Sets incorrectly assembled with wrong drip chamber

Medline fluid delivery sets were assembled with a macro drip chamber instead of the required micro drip chamber, delivering three times more fluid per drop and risking patient fluid overload.

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: This is an FDA Class I recall, which per the guidelines requires a minimum severity score of 4. No reported deaths or injuries are documented. The incorrect drip chamber assembly poses a significant risk of fluid overload in patients receiving infusion therapy.

Plain-English summary

Medline Industries is recalling 13,600 units of Fluid Delivery Sets with Drip Chambers distributed nationwide. The affected sets include five product variants with item numbers 99000069, 949000222, 949000224, 949000221, and 949000223.

The sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. A macro drip chamber delivers three times more fluid per drop than a micro drip chamber, resulting in incorrect fluid delivery rates to patients receiving infusion therapy.

Healthcare facilities and providers who have received these sets should stop using them immediately and contact Medline Industries for replacement. Patients currently receiving treatment with these sets should consult their healthcare provider regarding the potential for incorrect fluid delivery.

The recalled product

Product
Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RE
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Infusion / IV Equipment
Hazard
  • assembly-error
  • fluid-delivery-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 (18)

  • 1)99000069UDI-D:10193489069587(each)30193489069581(case)
  • Lot Number:0000128741
  • 2)99000069UDI-D:10193489069587(each)30193489069581(case)
  • Lot Number:0000134505
  • 3)99000069UDI-D:10193489069587(each)30193489069581(case)
  • Lot Number:0000133893
  • 4)99000069UDI-D:10193489069587(each)30193489069581(case)
  • Lot Number:0000135769
  • 5)99000069UDI-D:10193489069587(each)30193489069581(case)
  • Lot Number:0000139596
  • 6)949000222UDI-D:10197344018550(each)30197344018554(case)
  • Lot Number:0000133018
  • 7)949000224UDI-D:10197344018642(each)30197344018646(case)
  • Lot Number:0000136573
  • 8)949000221UDI-D:10197344018567(each)30197344018561(case)
  • Lot Number:0000133036
  • 9)949000223UDI-D:10197344018543(each)30197344018547(case)
  • Lot Number:0000133031

Distribution

Distributed nationwide across the United States.

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