The Recall Desk
HighFDA (Devices)·Z-2130-2012·Announced 2012-08-08

ICU Medical Recalls 94-inch IV Administration Sets Due to Molding Defect

ICU Medical is recalling specific lots of 94-inch IV administration sets because a molding defect may cause side ports to become occluded.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect that could impede fluid delivery, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.

Plain-English summary

ICU Medical, Inc. is recalling 94-inch (239cm) 20 Drop Administration Sets with High Pressure 4-Way Stopcock, Rotating Luer, and Non-DEHP Tubing. The recall involves Part Number B30059 (510(k) K964435) and specific lot numbers including 2418897, 2423996, 2425137, 2430044, 2431861, 2436569, 2443559, 2447238, 2448099, 2452377, 2457453, 2459025, 2464569, and 2467687. The products were distributed nationwide.

The firm initiated the recall due to a molding defect in the high-pressure stopcock. This defect may cause a small percentage of the side ports to become totally occluded. The source text does not report any illnesses or injuries associated with this defect.

Healthcare facilities and consumers should stop using the affected administration sets and contact ICU Medical, Inc. for further instructions or replacement.

The recalled product

Product
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
Manufacturer
ICU Medical, Inc.
Category
Medical Device — IV Administration Sets
Hazard

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 (14)

  • Part Number B30059 510(k) K964435 Lot number 2418897
  • 2423996
  • 2425137
  • 2430044
  • 2431861
  • 2436569
  • 2443559
  • 2447238
  • 2448099
  • 2452377
  • 2457453
  • 2459025
  • 2464569
  • 2467687.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · occlusion

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