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.
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 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
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
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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