ChemoLock Bag Spike, 01 units REF: CL-10-10
FDA device recall Z-0328-2026 · posted 2025-10-27 · Open, Classified
Recall details
- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Action taken
- On September 8, 2025, ICU Medical issued an "Urgent Medical Device" Recall notification via E-Mail. ICU Medical ask consignees to take the following actions: 1. Check all inventory locations within your institution for the affected products listed in recall notification and discontinue use. Destroy all affected products following your institution's process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 2. Share this notification with all potential users of the device, to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there. 3. Complete and return the attached Customer Response Form to marketaction@mailac.custhelp.com within 10 days of receipt to acknowledge your understanding of this notification. 4. If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to marketaction@mailac.custhelp.com For further inquiries, please contact ICU Medical Customer Service via email: customerservice@icumed.com or call: 1-(800)-258-5361 for additional information or technical assistance. Or contact Field Service Processing via email: marketaction@mailac.custhelp.com for Assistance with Customer Notifications and Response Forms.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- ONB
- Quantity affected
- 875 units
- Distribution
- Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to coun
- Date initiated
- 2025-09-08
- Date posted
- 2025-10-27
- Location
- San Clemente, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHEMOLOCK, CHEMOLOCK PORT (K131549) | Icu Medical, Inc. | 2013-07-26 |