FDA recall Z-2298-2021

Delta Med SpA · Class II · device

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 for recall

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

Distribution

US Nationwide distribution in the states of FL and MN.

Key facts

Status
Ongoing
Initiation date
2021-06-21
Report date
2021-08-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Viadana, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2298-2021