ICU Medical Recalls IV Sets with Potential Metallic Burrs in Stopcocks
ICU Medical is recalling specific IV administration sets because stopcocks may contain metallic burrs. The recall covers 24,475 units distributed in the US and Thailand.
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 3/5 (High).
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, and the hazard involves a physical defect (metallic burr) in a medical device that poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling certain intravascular administration sets, including various primary sets, extension sets, and stopcocks, because the stopcocks incorporated in these devices may contain a metallic burr. The affected products include multiple item numbers such as 066-C3352, B30167, and Z0106, among others.
The recall involves 24,475 units, with 17,225 distributed in the United States and the remainder distributed internationally to Thailand. The specific lot numbers affected are listed in the agency's recall record, including 3458321, 3462452, and 77-979-Y1.
Healthcare providers and consumers should check their inventory for the specific item and lot numbers listed in the FDA recall notice. If the affected products are found, they should be removed from use and returned to ICU Medical, Inc. according to the company's instructions.
The recalled product
- Product
- SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243; 10" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp…
- Manufacturer
- ICU Medical, Inc.
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 (20)
- Lot Number 3458321
- 3462452
- 3465813
- 3442569
- 3446005
- 3450752
- 3465816
- 3456237
- 3486340
- 3451451
- 3447667
- 3447427
- 3471329
- 3462010
- 3447673
- 3470589
- 3466170
- 3462856
- 77-979-Y1
- 76-113-Y1
Distribution
Distribution scope not specified by the agency.
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