Recall Z-2296-2021— Delta Med SpA

Name: FDA recall Z-2296-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-21

Class II · Ongoing

Class II FDA medical device recall by Delta Med SpA, initiated 2021-06-21. It names one FDA 510(k) clearance: K200373. 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 3810572 g) REF 3852572. Reason: Problems related to the sterilization of the medical devices; possible missing sterility of the medical device.

Recalling firm: Delta Med SpA
Classification: Class II
Status: Ongoing
Initiated: 2021-06-21
Firm location: Viadana, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K200373 — Deltaven Fast Flash Closed I.V. Catheter SystemsDelta Med Spa·cleared 2020-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.