FDA recall Z-2295-2021

Delta Med SpA · Class II · device

Product

DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272

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-2295-2021