The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0707-2021·Announced 2020-12-30

ICU Medical Recalls ChemoLock Administration Sets Due to Molding Defect

ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly lists potential consequences including 'exposure to hazardous medications' and 'blood loss,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk medical device defects, warranting a Severe rating.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of ChemoLock administration sets and ports. The affected products include various lengths of administration sets with integrated or in-line drip chambers and ChemoLock ports with Spiros connectors. The recall covers 88,700 units distributed nationwide in the United States and internationally in numerous countries including Canada, the United Kingdom, Germany, and Australia.

The recall is due to a molding defect in the spinning versions of male luers, which may exhibit leaks. This defect poses a risk of fluid leakage, which could potentially cause a delay in infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or air in the fluid path. The FDA has classified this as a Class II recall.

Healthcare facilities and consumers should stop using the affected products immediately. Users should check their inventory for the specific reference numbers and lot numbers listed in the official recall notice. If you have questions about this recall or need assistance, contact ICU Medical, Inc. directly.

The recalled product

Product
31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35…
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion Pumps & Sets
Hazard
Affected units
88,700

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 (17)

  • Lots: 4867937
  • 4751234
  • 4799262
  • 4894789
  • 4787230
  • 4867947
  • 4897075
  • 4720480
  • 4735684
  • 4758456
  • 4775068
  • 4794504
  • 4860043
  • 4799897
  • 4787234
  • 4808045
  • 4860044

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 13 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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