ChemosafeLock bag spikes recalled over port weld separation risk
ICU Medical is recalling 134,700 ChemosafeLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a weld that can break and leak on a drug transfer device is a hazard, and no injuries are reported.
Plain-English summary
The ICU Medical ChemosafeLock Bag Spike, REF KL-BS001U3, is being recalled.
The port weld of the drug transfer device may separate or break during use and potentially result in a leak.
The recall covers 134,700 units from lots 14399518, 14399521, 14406408, 14399520, 14406410 and 14406411. Distribution was worldwide, including nationwide in the United States and Japan. The FDA has classified the action as Class II.
The enforcement record describes the weld failure and reports no injuries. Because these spikes are used to transfer hazardous drugs, facilities should quarantine affected lots and follow ICU Medical's instructions.
The recalled product
- Product
- ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
- Manufacturer
- ICU Medical, Inc.
- Hazard
- weld-failure
- leak
- drug-transfer
- chemotherapy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot:14399518
- 14399521
- 14406408
- 14399520
- 14406410
- 14406411
- Distributed in Japan
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
FDA (Devices) · 2026-07-22
- LowRio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall
FDA (Devices) · 2026-07-22
- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella Introducer Kit recalled for potential fluid leakage
FDA (Devices) · 2026-07-22