FDAClass IIAugust 25, 2021

NEO DELTA Self Safe T recall: Sterility Concern

NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

Why was NEO DELTA Self Safe T recalled?

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) REF 3779422, Lot 00A1160635 b) REF 3769522, Lot 00A1160656 c) REF 3708522, Lot 00A1160638

Product
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Recalling firm
Delta Med SpA
Quantity
20,000 units
Distribution
US Nationwide distribution in the states of FL and MN.
Recall date
August 25, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls