133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2 Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage:
FDA device recall Z-0980-2017 · posted 2017-01-10 · Terminated
Recall details
- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.
- Action taken
- An Urgent Medical Device Recall Notification letter dated 11/30/16 was sent to their customers to inform them that ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber. The letter instructs the customers of the actions required and to return completed recall response form to ICU Medical via fax (801) 264-1755 or by email recall@icumed.com. Customers with questions are instructed to contact ICU Customer Service Monday through Friday between 8:30AM and 4PM Pacific Time, (866) 829-9025 and select option 2 or email productreturns@icumed.com.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FMG
- Quantity affected
- 225 units
- Distribution
- US: NC
- Date initiated
- 2016-11-30
- Date posted
- 2017-01-10
- Date terminated
- 2017-06-23
- 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 |