| | Class 2 Device Recall L70 HOTLINE WARMING SET |  |
| Date Initiated by Firm | June 24, 2026 |
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| Date Posted | July 17, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2759-2026 |
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| Recall Event ID |
99289 |
| 510(K)Number | K911383 |
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| Product Classification |
Warmer, thermal, infusion fluid - Product Code LGZ
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| Product | Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70 |
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| Code Information |
UDI-DI: 30695085407007;
Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349 |
| FEI Number |
3012307300
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Recalling Firm/
Manufacturer |
ICU Medical Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
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Manufacturer Reason
for Recall | ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond. |
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FDA Determined
Cause 2 | Process control |
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| Action | An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 6/24/26 was sent to customers.
Actions for Users:
When using the device, all instructions, including warnings and cautions contained in the Instructions for Use must be followed with heightened awareness. Please complete the following actions below.
1. Locate potentially affected devices from the Lots listed in Table 1 above.
2. 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.
3. 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 that this communication is delivered there.
4. 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.
Required Actions for Distributors:
When using the device, all instructions, including warnings and cautions contained in the Instructions for Use must be followed with heightened awareness. Please complete the following actions below.
1. Locate potentially affected devices from the Lots listed in Table 1 above.
2. 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.
3. 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 that this communication is delivered there.
4. 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.
5. DISTRIBUTORS: Immediately forward this notice to all users to whom you distributed these products. IC |
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| Quantity in Commerce | 39,750 units |
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| Distribution | Worldwide - US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LGZ
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