ICU Medical Recalls Infusion Sets with Incorrect Spin Collars
ICU Medical is recalling 7,600 sterile intravascular administration sets because they were manufactured with an incorrect spin collar. The sets were distributed in the US, Canada, and Japan.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect (incorrect spin collar) is a manufacturing error without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ICU Medical, Inc. is recalling 7,600 pouches of 14 cm (5.5") Smallbore Ext Set w/SURPLUG Nano T-Connector, Clamp, Rotating Luer, Item IR-NG31481B. The recall is due to the infusion sets being manufactured with an incorrect spin collar.
The affected sterile, single-use intravascular administration sets were distributed nationwide in the United States to Arizona, California, Colorado, Florida, South Carolina, and Texas, as well as to Canada and Japan. The recall covers four specific lot numbers: 3422861, 3489493, 3498769, and 3498773.
Healthcare providers and consumers should stop using the affected infusion sets and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 7,600
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 (8)
- Lot number 3422861
- UDI (01) 0 0840619 09588 8 (17) 200301 (30) 01 (10) 3422861
- lot number 3489493
- UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3489493
- lot number 3498769
- UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498769
- and lot number 3498773
- UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498773.
Distribution
Part of a larger recall action
This product is one of 6 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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