PlainRecalls
FDA Devices Moderate Class II Ongoing

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 3810572 g) REF 3852572

Reported: August 25, 2021 Initiated: June 21, 2021 #Z-2296-2021

Product Description

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 3810572 g) REF 3852572

Reason for Recall

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

Details

Recalling Firm
Delta Med SpA
Units Affected
203,680 units
Distribution
US Nationwide distribution in the states of FL and MN.
Location
Viadana, N/A

Frequently Asked Questions

What product was recalled?
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 3810572 g) REF 3852572. Recalled by Delta Med SpA. Units affected: 203,680 units.
Why was this product recalled?
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Which agency issued this recall?
This recall was issued by the FDA Devices on August 25, 2021. Severity: Moderate. Recall number: Z-2296-2021.