Agency classClass IIOur severity:High FDA (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.

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 3/5 (High).

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: occlusion
molding-defect

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 →

Same manufacturer · ICU Medical, Inc.

See all →

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Same hazard · occlusion