FDAClass IIAugust 25, 2021

DELTAVEN Safety I.V. Catheter in Pur with closed recall: Sterility Concern

DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272

Why was DELTAVEN Safety I.V. Catheter in Pur with closed 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 3836272, Lot 11T80188 b) REF 3814272, Lot 11T80272 c) REF 3845272, Lot 12T80147 d) REF 3856272, Lot 12T80347

Product
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Recalling firm
Delta Med SpA
Quantity
30,900 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