The Recall Desk
HighFDA (Devices)·Z-2299-2021·Announced 2021-08-25

I.V. Catheter Recall: Sterilization Defects in NEO DELTA Self Safe Devices

Delta Med is recalling 10,000 units of NEO DELTA Self Safe I.V. Catheters due to sterilization defects. Affected devices were distributed in Florida and Minnesota.

What this means for you

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: This is an FDA Class II recall involving potential sterilization defects in a medical device. No illnesses, hospitalizations, or injuries are reported in the source material. Per the rubric, when no harm is reported and the hazard is theoretical, the maximum score is High (3).

Plain-English summary

Delta Med SpA is recalling 10,000 units of the NEO DELTA Self Safe I.V. Catheter (Reference 3738222, Lot 00A1160625) due to sterilization defects. The devices may lack adequate sterilization.

Non-sterile I.V. catheters pose safety risks when placed in patients. A catheter that is not properly sterilized can introduce bacterial contamination and infection during or after medical procedures.

The affected devices were distributed nationwide in Florida and Minnesota. Patients who received this device should consult their healthcare provider about their treatment history. Healthcare facilities in these states should follow the manufacturer's instructions for managing recalled devices.

The U.S. Food and Drug Administration is overseeing this Class II recall.

The recalled product

Product
NEO DELTA Self Safe, I.V. Catheter REF 3738222
Manufacturer
Delta Med SpA
Category
Medical Device — I.V. Catheter
Hazard
  • non-sterile
  • sterilization-defect

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 (2)

  • REF 3738222
  • Lot 00A1160625

Distribution

Distributed nationwide across the United States.

Related recalls

Same category