Agency classClass IIOur severity:High FDA (Devices)·Z-2295-2014·Announced 2014-08-27

ICU Medical Recalls Port Access Kits with Potential Sterility Issues

ICU Medical is recalling Port Access Kits with MicroClave Clear Connectors because some packages may have open seals, potentially compromising sterility.

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 where a defect (open seals) potentially compromises sterility, creating a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling the Port Access Kit with MicroClave Clear Connector, Item No. B79104. The recall involves 400 units of Lot No. 2705203 that were distributed nationwide in the United States, including Alabama and Maryland. The affected lots are identifiable by the lot number printed on the pouch.

The recall is being issued because some unit packages may exhibit open seals. This defect impacts package sterility and potentially product sterility. The product includes BD prefilled syringes co-packaged with ICU devices and other components.

Healthcare providers and consumers should stop using the affected units and contact ICU Medical for further instructions or a replacement.

The recalled product

Product: Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Syringes and Infusion Devices
Hazard: sterility-compromise
infection-risk
Affected units: 400

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 (1)

Lot No. 2705203

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · ICU Medical, Inc.

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