ICU Medical Recalls 7-inch Intravascular Administration Sets with Incorrect Spin Collar
ICU Medical is recalling 250 pouches of 7-inch intravascular administration sets because they were manufactured with an incorrect spin collar.
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: The recall is classified as FDA Class II for a medical device with a manufacturing defect (incorrect spin collar). No specific injuries or illnesses are reported in the source text, but the defect in a sterile intravascular device presents a risk of harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 250 pouches of 7-inch Intravascular Administration Sets (Item AH7262). The affected lots are 3483247, 3484722, and 3489328. These single-use, sterile devices are used to administer fluids from a container to a patient's vascular system.
The recall was initiated because the infusion sets were manufactured with an incorrect spin collar. The agency has classified this recall as Class II.
The affected products were distributed nationwide in the United States to Arizona, California, Colorado, Florida, South Carolina, and Texas, as well as to Canada and Japan. Consumers and healthcare facilities should stop using the affected products and contact ICU Medical for further instructions.
The recalled product
- Product
- 7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 250
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 (6)
- Lot number 3483247
- UDI(01) 0 0887709 08949 5 (17) 220601 (30) 01 (10) 3483247
- lot number 3484722
- UDI(01) 0 0887709 08949 5 (17) 220601 (30) 01 (10) 3484722
- and lot number 3489328
- UDI (01) 0 0887709 08949 5 (17) 220701 (30) 01 (10) 3489328.
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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