FDAClass IIAugust 25, 2021

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

DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF…

Why was DELTAVEN Y DNL 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 3832572: Lot 11T80189 b) REF 3842572, Lot 11T80198 c) REF 3821572, Lot 11T80149 d) REF 3833572, Lot 11T80292 e) REF 3831572, Lot 12T80230 f) REF 3810572, Lot 12T80302 g) REF 3852572, Lot 12T80349

Product
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF…
Recalling firm
Delta Med SpA
Quantity
203,680 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