Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device w
FDA device recall Z-2721-2017 · posted 2017-06-26 · Terminated
Recall details
- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
- Action taken
- Customers were notified via letter on approximately 05/30/2017 and were instructed to examine their inventory, quarantine affected products, complete and return the response form, and return to ICU Medical. If there are any questions or assistance needed, customers can call ICU Customer Service Monday through Friday between 8:30 AM and 4:00 PM Pacific time: 866-829-9025. Or they can email: Productreturns@icumed.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FMG
- Quantity affected
- 100 units
- Distribution
- Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
- Date initiated
- 2017-05-30
- Date posted
- 2017-06-26
- Date terminated
- 2024-09-20
- 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 |