ICU Medical Recalls Tego Connectors Due to Potential Leaking Risk
ICU Medical is recalling Tego Connectors due to a potential risk of leaking. The devices are used as accessories for vascular access in hemodialysis.
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. The hazard is a potential leak in a medical device used for vascular access, which poses a risk of harm, but no injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling Tego Connector devices, Item No. D1000 and NM1000, due to a potential risk of leaking. The Tego Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery.
The recall involves 476,600 units. The devices were distributed nationwide in the United States and in several countries, including Saudi Arabia, Germany, Austria, Belgium, Estonia, Poland, Switzerland, Canada, Luxembourg, Netherlands, Bulgaria, Malaysia, Italy, Ireland, Great Britain, France, Brazil, Sweden, Slovenia, and Portugal.
The source text does not specify specific actions for consumers or healthcare providers beyond the identification of the risk. Healthcare facilities should check their inventory for the affected lot codes listed in the recall notice.
The recalled product
- Product
- Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids…
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 476,600
Distribution
Distributed nationwide across the United States.
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