Agency classClass IIOur severity:High FDA (Devices)·Z-2293-2014·Announced 2014-08-27

ICU Medical Recalls CAP Change Kits Due to Potential Sterility Issues

ICU Medical is recalling CAP Change Kits with MicroClave Clear 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. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

ICU Medical, Inc. is recalling the CAP Change Kit w/MicroClave Clear, Item No. B78109. This product consists of BD prefilled syringes co-packaged with ICU devices and other components. The recall is limited to 300 units distributed nationwide in the United States, including Alabama and Maryland. The affected lots are identified by the lot numbers 2704633 and 2705206, which are printed on the pouch.

The recall was initiated because some unit packages may exhibit open seals. This defect impacts package sterility and potentially product sterility. The source text does not report any specific illnesses or injuries associated with this recall.

Healthcare providers and consumers should check the lot numbers on the pouch of the CAP Change Kit w/MicroClave Clear. If the lot number matches 2704633 or 2705206, the product should be stopped and returned to the supplier or the manufacturer.

The recalled product

Product: CAP Change Kit w/MicroClave Clear, Item No. B78109 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 / Infusion Components
Hazard: sterility-compromise
infection-risk
Affected units: 300

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 (2)

Lot No. 2704633
2705206

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.

See all →

High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23

Same hazard · sterility compromise