Unomedical Infusion Set Needles Recalled for Potential Breakage During Use
Unomedical is recalling specific infusion sets because the steel needle can break during use, interrupting medication delivery.
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 involves a medical device where a defect (needle breakage) can interrupt the delivery of critical medication like insulin. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as the source text does not state that any injuries or illnesses have occurred.
Plain-English summary
Unomedical As is recalling specific models of infusion sets, including Sure T, Contact, Contact Detach, Neria, Neria Detach, Neria Multi, and Thalaset. These products are used in combination with infusion pumps for the continuous subcutaneous infusion of medication.
The recall was initiated because Unomedical found that in rare cases, the steel needle can break during use. This breakage can interrupt the delivery of medication, including insulin. The affected units were distributed worldwide, including in the United States and numerous international markets.
Consumers should check their infusion sets against the list of affected lot codes provided in the official recall notice. If a user has a product with an affected lot code, they should stop using it and contact Unomedical for instructions on replacement or refund.
The recalled product
- Product
- Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
- Manufacturer
- Unomedical As
- Category
- Medical Device — Infusion Sets
- Affected units
- 22,976,870
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)
- 210131
- 212482
- 213575
- 213576
- 214509
- 214511
- 216175
- 216295
- 216296
- 218110
- 218111
- 218685
- 219030
- 219075
- 220160
- 220161
- 220163
- 223771
- 224282
- 224283
Distribution
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