CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report
ChemoLock Vented Vial Spike recalled by ICU Medical
ICU Medical is recalling ChemoLock Vented Vial Spike, distributed nationwide in the US. The recall was initiated on 8 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0344-2026
- FDA event ID
- 97583
- Recalling firm
- ICU Medical, San Clemente, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Sep 2025
- FDA classified
- 27 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 8 Sep 2025 | Recall initiated by company | |
| 27 Oct 2025 | Classified by FDA | +49 days |
| 5 Nov 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMississippiMontana
Questions about this recall
Why was it recalled?
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Which lots are affected?
UDI:10887709067155/Lot:14379176
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
37 other products · FDA event 97583This product is part of a recall event; the main page for the event is ChemoLock Closed Vial Spike w/Skirt recalled by ICU Medical.
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