ICU Medical Recalls Infusion Sets with Incorrect Spin Collars
ICU Medical is recalling specific lots of sterile intravascular administration sets because they were manufactured with an incorrect spin collar.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving a manufacturing defect without reported harm.
Plain-English summary
ICU Medical, Inc. is recalling 550 pouches of 6.5-inch Trifuse Ext Sets (Item A1254) due to a manufacturing defect. The affected infusion sets were manufactured with an incorrect spin collar. The recalled product is a single-use, sterile, non-pyrogenic device used to provide access for the administration of fluids from a container to a patient's vascular system.
The recall includes lot numbers 3533699 and 3549590. These products were distributed nationwide in the United States to Arizona, California, Colorado, Florida, South Carolina, and Texas, as well as to Canada and Japan. The source text does not specify the exact number of units distributed in each location or the specific dates of distribution.
Healthcare providers and consumers should check their inventory for the specific lot numbers and UDI codes listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single…
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 550
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 (4)
- Lot number 3533699
- UDI (01) 0 0887709 09040 8 (17) 220901 (30) 01 (10) 3533699
- and lot number 3549590
- UDI (01) 0 0887709 09040 8 (17) 221001 (30) 01 (10) 3549590.
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.
See all 6 products in this recall →Related recalls
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