Z-0360-2026Class II
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
Abbott Medical / initiated 2025-09-08 / Open, Classified / root cause: manufacturing process
ICU Medical, Inc. began a recall of ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967 on . FDA classified it as Class II and gives the reason as "Port weld of drug transfer device may separate or break during use and potentially result in a leak". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0360-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Abbott Medical
- Product
- ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
- Product code
- ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Reason for recall
- Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Root cause tag
- manufacturing process
- FDA root cause
- Under Investigation by firm
- Action
- 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 [email protected] 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 [email protected] For further inquiries, please contact ICU Medical Customer Service via email: [email protected] or call: 1-(800)-258-5361 for additional information or technical assistance. Or contact Field Service Processing via email: [email protected] for Assistance with Customer Notifications and Response Forms.
- Quantity in commerce
- 5700 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 countries of: Canada, France, and Japan.
- Product codes and lots
- Lot:14369083 14386090 14391965; Distributed in Canada
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0328-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0329-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0330-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0331-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0332-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0333-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0334-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0335-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0336-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0337-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0338-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0339-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0340-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0341-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0342-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0343-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0344-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0345-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0346-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0347-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0348-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0349-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0350-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0351-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0352-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0353-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0354-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0355-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0356-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0357-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0358-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0359-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0360-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0361-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0362-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0363-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0364-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0365-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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