The Recall Desk
HighFDA (Devices)·Z-2304-2021·Announced 2021-08-25

I.V. Catheter Recall Due to Possible Sterilization Failure

Delta Med recalls NEO DELTA SELFSAFE PUR T I.V. catheters distributed in Florida and Minnesota due to sterilization problems. Non-sterile catheters pose infection risks.

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 for a risk-of-harm medical device with sterilization defects, but no reported illnesses or injuries. Per the rubric, theoretical hazards without reported injury score at most 3 (High).

Plain-English summary

Delta Med SpA is recalling NEO DELTA SELFSAFE PUR T I.V. catheters distributed in Florida and Minnesota. The catheters have sterilization defects and may lack sterility.

Non-sterile I.V. catheters pose a risk of infection when inserted. The affected product has Reference numbers 3738522 (Lot 00A2160813) and 3738822 (Lot 00A1160822).

Patients and healthcare providers who have or may have used these catheters should contact Delta Med SpA or their healthcare provider immediately. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
NEO DELTA SELFSAFE PUR T, I.V. Catheter:
Manufacturer
Delta Med SpA
Category
Medical Device — I.V. 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)

  • REF 3738522
  • Lot 00A2160813 REF 3738822
  • Lot 00A1160822

Distribution

Distributed nationwide across the United States.

Related recalls

Same category