NEO DELTA Self Safe T IV Catheters Recalled for Sterilization Failure
NEO DELTA Self Safe T IV catheters may lack sterility due to sterilization problems. The FDA is recalling 20,000 units distributed in Florida and Minnesota.
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: FDA Class II recall involving a high-risk device (IV catheter) where sterilization integrity is compromised. No illnesses or injuries have been reported, making this a theoretical hazard rather than a confirmed harm event.
Plain-English summary
Delta Med SpA is recalling the NEO DELTA Self Safe T IV catheter due to sterilization defects that may result in missing sterility of the medical device. The recall involves three reference models: REF 3779422, REF 3769522, and REF 3708522.
20,000 units have been recalled. The affected units were distributed nationwide in Florida and Minnesota. The specific affected lot numbers are Lot 00A1160635 (REF 3779422), Lot 00A1160656 (REF 3769522), and Lot 00A1160638 (REF 3708522).
Healthcare facilities and healthcare providers in possession of these catheters should immediately cease using them and verify their inventory against the affected lot numbers. Contact Delta Med SpA or your medical device supplier for replacement units or return instructions.
The recalled product
- Product
- NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
- Manufacturer
- Delta Med SpA
- Category
- Medical Device — IV Catheter
- Hazard
- Affected units
- 20,000
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)
- a) REF 3779422
- Lot 00A1160635 b) REF 3769522
- Lot 00A1160656 c) REF 3708522
- Lot 00A1160638
Distribution
Part of a larger recall action
This product is one of 11 recalled by Delta Med SpA 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 11 products in this recall →Related recalls
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