IV Catheters Recalled by FDA for Sterilization Defects
Delta Med is recalling NEO DELTA SELFSAFE PUR T IV catheters due to possible sterilization failures. The recall affects 14,000 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 with potential for harm but no reported illnesses or injuries. Non-sterile IV catheters present infection risk, meeting the rubric criteria for High severity as a risk-of-harm product without injury reports.
Plain-English summary
Delta Med SpA is recalling NEO DELTA SELFSAFE PUR T I.V. catheters due to sterilization defects. Two catalog references are affected: REF 3738522 (Lot 00A2160813) and REF 3738822 (Lot 00A1160822). The recall involves 14,000 units.
The devices may lack proper sterilization, which could introduce infection risk to patients receiving IV therapy.
The affected catheters were distributed in Florida and Minnesota. Healthcare providers and patients with these products should discontinue use and contact Delta Med SpA or the FDA for return instructions and replacement options.
The recalled product
- Product
- NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
- Manufacturer
- Delta Med SpA
- Category
- Medical Device — IV Catheter
- Affected units
- 14,000
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 (3)
- a) REF 3738522
- Lot 00A2160813 b) REF 3738822
- Lot 00A1160822
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
Same manufacturer · Delta Med SpA
See all →- HighDELTAVEN Y IV Catheters Recalled Over Potential Sterilization Defect
FDA (Devices) · 2021-08-25
- HighI.V. Catheter Recall: Sterilization Defects in NEO DELTA Self Safe Devices
FDA (Devices) · 2021-08-25
- HighI.V. Catheter Recall Due to Possible Sterilization Failure
FDA (Devices) · 2021-08-25
- HighNEO DELTA Self Safe T IV Catheters Recalled for Sterilization Failure
FDA (Devices) · 2021-08-25
- HighFDA Recalls DELTAVEN Y Safety IV Catheters Due to Sterilization Issues
FDA (Devices) · 2021-08-25
Same hazard · sterilization failure
See all →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- SevereMedline Catheterization Kits Recalled for Potential Sterility Defect
FDA (Devices) · 2024-03-06
- HighMedline Suction Catheters Recalled for Sterilization Error
FDA (Devices) · 2017-11-29
- HighMedline Pediatric Suction Catheters Recalled for Sterilization Error
FDA (Devices) · 2017-11-29
- HighAmerican Catheter Recalls Cholangiogram Catheters Due to Sterilization Seal Failure
FDA (Devices) · 2015-07-29
- HighMedtronic IN.PACT AV Balloon Catheter: Damaged Packaging May Affect Sterility
FDA (Devices) · 2022-05-18
- SevereMedline Surgical Kits Recalled for Potential Lack of Sterility
FDA (Devices) · 2024-03-06