FDA Medical Device Recalls (openFDA)
ICU Medical, Inc.: 98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
- Recall number
- Z-1594-2015
- Recalling firm
- ICU Medical, Inc.
- Product
- 98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
- Status
- Terminated
- Initiated
- 2015-04-20
- Posted
- 2015-05-07
- Terminated
- 2015-11-24
- Reason
- ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
- Root cause
- Under Investigation by firm
- Action
- An Urgent Medical Device Recall letter dated 4/17/15 will be sent to customers on 4/20/15 to inform them that ICU Medical Inc. has identified a potential connection separation issue in a small number of isolated Intravenous Administration Transfer Sets. While the separation may be visually detected, if used, this failure mode could lead to leakage. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to return completed recall response form to ICU Medical by Fax at (801) 264-1755 or email to recall@icumed.com. Customers with questions or require assistance relating to the recall are instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com.
- Quantity
- 900 units
- Distribution
- Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN
- Lot, serial or model codes
- Lot No. 2997914 2997918 2998570 3001230 3001231
- 510(k) numbers
- ["K964435"]
- PMA numbers
- not on file
- Product code
- FMG
- Firm FEI
- 2025816
- Firm city
- San Clemente
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28