SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer
FDA device recall Z-0106-2018 · posted 2017-11-17 · Terminated
Recall details
- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- ICU Medical has identified certain stopcocks that are incorporated in IV sets may contain a metallic burr.
- Action taken
- ICU Medical, Inc. sent an Urgent Medical Device Recall Notification dated August 31, 2017. Customers will be instructed to quarantine any devices and return to ICU. Recipients will be instructed to continue the recall through to the end user of the device. Please call Customer Service, Monday through Friday between the hours of 7 am through 4:30pm CST @ 877-946-7747 and select option 9, or e-mail the following address: Productreturns@icumed.com
- Root cause
- Manufacturing material removal
- Status
- Terminated
- Product code
- FMG
- Quantity affected
- 24,475 (17,225 in US)
- Distribution
- US Distribution and Internationally to TH.
- Date initiated
- 2017-08-31
- Date posted
- 2017-11-17
- Date terminated
- 2018-10-17
- 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 |