98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rota
FDA device recall Z-1594-2015 · posted 2015-05-07 · Terminated
Recall details
- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- FMG
- Quantity affected
- 900 units
- Distribution
- Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN
- Date initiated
- 2015-04-20
- Date posted
- 2015-05-07
- Date terminated
- 2015-11-24
- Location
- San Clemente, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMARY IV SET (K964435) | Icu Medical, Inc. | 1997-04-02 |