FDA recall Z-2301-2021

Delta Med SpA · Class II · device

Product

NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

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-2301-2021