Food, drugs, devices › ICU Medical, Inc.
Device recall: ChemoLock Bag Spike, 01 units REF: CL-10-10
FDA enforcement event 97583 is a device recall by ICU Medical, Inc. of San Clemente, CA, initiated 8 Sep 2025 and classified Class II, with 38 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. ICU Medical, Inc. has 75 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
ICU Medical, Inc., San Clemente, CA.
Reason for recall
"Port weld of drug transfer device may separate or break during use and potentially result in a leak."
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0328-2026 | ChemoLock Bag Spike, 01 units REF: CL-10-10 | 875 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0329-2026 | ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10 | 2100 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0330-2026 | ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS | 2000 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0331-2026 | ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 | 200 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0332-2026 | ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011 | 11000 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0333-2026 | ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511 | 7950 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0334-2026 | ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929 | 1100 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0335-2026 | ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940 | 3000 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0336-2026 | ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136 | 150 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0337-2026 | ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138 | 600 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0338-2026 | ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151 | 950 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0339-2026 | ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173 | 200 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0340-2026 | ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176 | 200 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0341-2026 | ICU Medical ChemoLock Bag Spike REF: CL-10 | 7850 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0342-2026 | ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 | 4000 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0343-2026 | ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 | 16850 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0344-2026 | ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S | 11200 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0345-2026 | ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 | 9004 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0346-2026 | ICU Medical ChemoLock Closed Vial Spike REF: CL-80 | 6150 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0347-2026 | ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S | 53,050 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0348-2026 | ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 | 8475 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0349-2026 | ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 | 3350 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0350-2026 | ICU Medical ChemoLock Port REF: CL2100 | 133,255 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0351-2026 | ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360 | 950 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0352-2026 | ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 | 1700 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0353-2026 | ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955 | 6450 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0354-2026 | ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20 | 80 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0355-2026 | ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17 | 400 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0356-2026 | ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34 | 900 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0357-2026 | ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 | 2000 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0358-2026 | ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950 | 2450 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0359-2026 | ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951 | 11000 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0360-2026 | ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967 | 5700 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0361-2026 | ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118 | 1600 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0362-2026 | ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188 | 200 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0363-2026 | ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3 | 134700 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0364-2026 | ICU Medical ChemosafeLock Connecter REF: KL-FNU3 | 134,700 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0365-2026 | ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3 | 202900 units | Class II | Ongoing | 5 Nov 2025 |
Context
Other enforcement events for ICU Medical, Inc.
All 75 events for ICU Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Port weld of drug transfer device may separate or break during use and potentially result in a leak."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.