The Recall Desk
HighFDA (Devices)·Z-2303-2021·Announced 2021-08-25

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.

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: 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
Hazard
  • sterilization-failure
  • infection-risk

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

Distributed nationwide across the United States.

Related recalls

Same category