Recall Z-2298-2021— Delta Med SpA

Name: FDA recall Z-2298-2021
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: K171530. Product: DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072. 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

K171530 — Deltaven XiV Max, Deltaven XiV Max FFDelta Med Spa·cleared 2017-12-21

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, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072

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.